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American Journal of Speech-Language Pathology logoLink to American Journal of Speech-Language Pathology
. 2025 Mar 28;34(3):1425–1434. doi: 10.1044/2025_AJSLP-23-00464

Feasibility of Endoscopic Evaluations of Laryngeal Function After Extubation for Research in Critically Ill Adults

Vinciya Pandian a,b,c,✉, Sai Phani Sree Cherukuri d, Mounica Koneru e, Gowthami Sai Kogilathota Jagirdhar Reddy f, Pooja Kota g, Victor D Dinglas b,h, Elizabeth Colantuoni b,i, Lee Akst j,k, Alexander T Hillel k, Dale M Needham b,l,m, Martin B Brodsky b,h,l,n, with the PALSS study team
PMCID: PMC12083763  PMID: 40153258

Abstract

Purpose:

Flexible nasal laryngoscopy (FNL) is commonly used in intensive care units (ICUs) to assess laryngeal anatomy and function after endotracheal intubation. The use of FNL in research may differ from clinical practice due to requirements of research protocols and related data collection and documentation. This study evaluates the feasibility of performing FNL post-extubation in critically ill adults within the context of a research protocol. Understanding the feasibility of this reference standard assessment is important for supporting future studies and improving patient care.

Method:

This prospective study, conducted in six ICUs within a single academic medical center, consecutively enrolled adult patients who required mechanical ventilation for at least 8 hr. The primary feasibility outcome was the successful completion of FNL within 72 hr of extubation. Secondary outcomes included completion of the 3-oz water swallow test (Yale Swallow Protocol) during the FNL, patient enrollment/exclusion/withdrawal rates, time from extubation to FNL, procedure duration, and patient-reported pain (using the Wong–Baker FACES Pain Rating Scale).

Results:

A total of 80 patients (75%) of 107 eligible patients fully completed FNL. Among the 24 patients who did not receive FNL, eight died, seven were medically inappropriate, and seven declined FNL. The median time from extubation to FNL was 10 hr (IQR [interquartile range]: 8–12 hr), and the median FNL procedure duration was 8.5 min (IQR: 5.8–12.9 min). The median (IQR) pain score was 2 (0, 4) of 10, reflecting only mild discomfort.

Conclusion:

Post-extubation FNL is feasible within the context of a research protocol and well tolerated by critically ill adults.

Globally, endotracheal intubation for mechanical ventilation in the intensive care unit (ICU) occurs in 20 million patients annually (Adhikari et al., 2010; Mehta et al., 2015). However, the complications of intubation—including voice disorders (dysphonia); airway and breathing difficulties due to stenosis, fistula, or tracheomalacia; and swallowing disorders (dysphagia)—can result in sequelae after ICU discharge (Brodsky et al., 2018). Compounding this issue is the growing number of adults requiring mechanical ventilation due, in part, to the aging population (Bouza et al., 2021; Lee et al., 2022).

Within the context of a research protocol evaluating critically ill adults, there is limited and inconsistent evidence regarding the feasibility of performing flexible nasal laryngoscopy (FNL) to evaluate laryngeal anatomy and function after patients are extubated from mechanical ventilation (Skoretz et al., 2017). For instance, the prior study by Leder et al. (2019) did not include a patient flow diagram, which limits the transparency and interpretability of critical feasibility metrics, such as patient recruitment, enrollment, and attrition. The absence of such data restricts reproducibility and the ability to fully understand procedural challenges, which are essential for designing future studies. Understanding the feasibility of this reference standard assessment is crucial to help support future research studies seeking funding and potentially lead to future discoveries that may enhance patient care. Additionally, there are gaps in the methodology and reporting of clinical research studies that explore laryngeal anatomy and function. For instance, one study that consecutively enrolled 100 patients lacked a patient flow diagram, which precludes detailed insights into patient recruitment and retention (Shinn et al., 2019). Our study will report on patient screening and consecutive enrollment under a research protocol, incorporating an assessment of multiple feasibility issues. Furthermore, data on the feasibility of FNL and the water swallow test as per the Yale Swallow Protocol (YSP) for research purposes will be reported to add to existing data in this area (Leder & Suiter, 2014).

Within the context of a National Institutes of Health–funded research study that prospectively enrolls critically ill patients post-extubation in the ICU, our primary objectives were to (a) assess the feasibility of completing FNL for assessments of laryngeal anatomy and function post-extubation and (b) identify and characterize challenges and facilitators associated with completing FNL post-extubation. Our secondary objective was to determine the feasibility and challenges of concurrently conducting the YSP with FNL post-extubation. Understanding these feasibility issues can provide insights to inform research and ultimately enhance patient care.

Method

Ethical Considerations

This report is part of a larger ongoing study, the Post-extubation Assessment of Laryngeal Symptoms and Severity (PALSS) study, which has received approval from the institutional review board at Johns Hopkins Medicine and was registered at ClinicalTrials.gov (NCT03726086). Informed consent was obtained from the patient, or a legally authorized representative (LAR) if the patient did not have capacity for medical decision making, and then assent for study procedures were obtained from patients who lacked capacity.

Study Design and Setting

PALSS is a prospective cohort study conducted in six ICUs (one medical, one medical oncology, one medical cardiology, two general/trauma/oncology surgery, and one cardiovascular surgery) at a single academic medical center. The larger study aimed at elucidating the etiology and pathophysiology of voice and airway complications associated with endotracheal intubation in patients undergoing mechanical ventilation and empirically assessing approaches to clinician screening for such complications.

Participants

Consecutive patients admitted to the study site ICUs were screened for eligibility based on a review of electronic medical records. Inclusion criteria were (a) adult (≥ 18 years old), (b) mechanical ventilation via an oral endotracheal tube, and (c) anticipated intubation duration ≥ 8 hr in the ICU, as per the clinical judgment of the ICU care team based on the patient's medical status and projected clinical course. Exclusion criteria were (a) preexisting dysphonia or dysphagia; (b) preexisting central nervous system, neuromuscular, or connective tissue disease associated with impairment in phonation and swallowing; (c) history of major thoracic surgery (e.g., sternotomy) prior to the current hospital admission; (d) head and neck disease or surgery (excluding tonsillectomy) associated with impairment in phonation or swallowing; (e) known or suspected anatomical abnormalities or preintubation trauma of the oral cavity, pharynx, larynx, or esophagus; and (f) unlikely to be extubated (i.e., expected death), as determined by the clinical team.

Procedure

The FNL was completed with a PENTAX Medical laryngoscopy workstation equipped with a 2.4-mm flexible naso-pharyngo-laryngoscope (VNL8-J10). Patients did not receive any medication to complete FNL (i.e., no nasal decongestant or topical anesthetic and no intravenous medication). In consultation with the clinical team, the appropriateness of the patient for study evaluation was determined through sequential steps as listed in Table 1.

Table 1.

Study procedures.

Step Description Procedure type
Step 1 Review of the patient's electronic medical record for relevant laboratory values (e.g., platelet count), medication history (e.g., anticoagulants), oxygen and respiratory support, and vital signs. Medical concern
Coagulation status: Laryngoscopy was completed with platelet count ≥ 20,000/mm3. If platelet count < 20,000/mm3, laryngoscopy was performed in discussion with the clinical team, assessing the risk of nose bleed; most recent transfusion information; any risk, suspicion of, or current active bleeding; other relevant laboratory data (e.g., INR); and whether the patient is on anticoagulant medications. Medical concern
Oxygenation and respiratory support: Laryngoscopy was completed in the absence of noninvasive mechanical ventilation and was carefully considered in discussion with the clinical team if high flow nasal cannula with > 60% FiO2 and/or > 60 L/min. Medical concern
Vital signs: Laryngoscopy was initiated in patients with heart rate > 60 bpm and < 120 bpm without any clinically important arrhythmia, and with blood pressure < 150/100 mm Hg. Approval from the clinical team is sought in the setting of vasopressor infusion. Medical concern
Step 2 Study team communicated with the clinical team to obtain the patient's current medical status, mental status, and feasibility. If visitors are present, understanding their interaction with the patient is helpful. IRB procedure; medical concern
Study team sought to obtain permission from the clinical team to approach the patient and/or the patient's legally authorized representative (if patient lacked capacity) for informed consent. IRB procedure
Study team obtained informed consent from the patient or the legally authorized representative. IRB procedure
Step 3 Endoscopy is completed only if the patient has a RASS −1, 0, +1, or +2 and able to follow minimal instructions to participate in the procedure. Study procedure
Step 4 Study team administered 2 brief questionnaires to characterize the patient's voice, and complete an oral motor physical examination to determine whether the patient is able to maintain attention and follow simple directions immediately prior to completing endoscopy. Study procedure
Step 5 After clearing the patient across all of these criteria and addressing any concerns with the clinical team, the study team proceeded with the flexible nasal laryngoscopy. The patient's vital signs (e.g., pulse oximetry, blood pressure, heart rate, respiratory rate), supplemental oxygen and its mode of delivery (e.g., nasal cannula), and vasopressor requirements were noted pre- and post-procedure. Study procedure
Step 6 After completion of the laryngoscopy, findings were reviewed and discussed with the patient and the clinical team if moderate or severe laryngeal injury was present. Moderate-to-severe laryngeal injuries found during assessment were also discussed with fellowship-trained laryngologist co-investigators. Concerning images and video were shared with the laryngologists and clinical team to determine the need for further evaluation and clinical referral. Study procedure; clinical care
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Outcomes

The primary outcome was the completion of FNL to evaluate laryngeal anatomy and function within 72 hr of extubation. This time frame was selected to balance competing factors. More specifically, a relatively short-interval post-extubation is essential for timely detection of any potential laryngeal injury before natural healing may obscure the initial extent of the damage. However, the period must not be too brief to ensure the feasibility of conducting these assessments across all days, including weekends and holidays, thereby accommodating the operational realities of clinical and research settings. Although there is no clear standard regarding the optimal timing for such evaluations, a specific cutoff time is required in the context of a research protocol. The completion of FNL was categorized into three levels: Not Attempted, where FNL was not initiated; Partially Completed, where FNL was initiated but not all protocol aspects were fulfilled, resulting in incomplete assessment data; and Fully Completed, where FNL adhered to all protocol stipulations, allowing for a comprehensive evaluation of laryngeal anatomy and function.

To identify potential challenges associated with completing FNL evaluation after extubation, within the context of a research protocol, secondary outcomes included patient enrollment/exclusion/withdrawal, time (in hours) between extubation and FNL, sedation/agitation status via the Richmond Agitation Sedation Scale (RASS; Ely et al., 2003), delirium status via Confusion Assessment Method for the ICU (CAM-ICU; Ely, Inouye, et al., 2001; Ely, Margolin, et al., 2001), duration (in minutes) of the FNL procedure, and patient pain measured via Wong-Baker FACES (Wong-Baker FACES Foundation, 2018).

We also evaluated the frequency of successful completion of the YSP (Leder & Suiter, 2014). At our institution, FNL post-extubation is selectively conducted by speech-language pathologists (SLPs), primarily for patients in whom there are possible abnormalities based on a screening water swallow test performed by ICU nurses, those patients who have concerns with voice or swallow based on other clinical evaluations or with prior swallowing or speech problems. In this research protocol, we consecutively enrolled eligible extubated patients, independent of clinical orders for SLP evaluation. SLPs joined the assessment where clinical referrals for SLP were present as per medical order by a physician or advanced practice provider.

Data collection included patient demographics (age, sex, and race); baseline clinical characteristics, including body mass index (BMI), Acute Physiology and Chronic Health Evaluation (APACHE) II severity of illness score (Knaus et al., 1985), Sequential Organ Failure Assessment (SOFA) score (Vincent et al., 1996), source and type of admission, and primary admitting diagnosis; and clinical course (e.g., duration of mechanical ventilation and ICU and hospital lengths of stay).

Statistical Analysis

Descriptive statistics were used to summarize data on patient characteristics and study outcomes, with statistical comparisons conducted using Wilcoxon rank sum, chi-square, and Fisher's exact tests, as appropriate. Statistical analysis was conducted using Stata Statistical Software (StataCorp, 2023).

Results

Patient Enrollment

The screening period for patient enrollment in this report spanned 13 months from February 2019 to March 2020 (parent study is ongoing), with a total of 1,321 mechanically ventilated adults having an anticipated intubation duration of at least 8 hr. After study exclusion criteria were identified in 1,029 patients, there were 292 (22%) patients eligible. Of these, 185 (63%) were not enrolled due to declined consent (30%), physicians declining study participation (24%), and inaccessibility of LARs for informed consent (9%). Hence, 107 patients were enrolled in the study (Figure 1).

Figure 1.

A flow chart for the enrollment process. The steps are as follows. Step 1. Mechanically ventilated, n equals 1321 participants. 1029 participants which is 78 percent of the participants did not meet inclusion criteria. The breakup of the excluded participants is as follows. 176 participants (17 percent) central nervous system disorder. 158 participants (15 percent) head and neck disease or surgery. 147 participants (14 percent) major thoracic surgery. 139 participants (14 percent) missed or not recruiting. 111 participants (11 percent) expected to die. 88 participants (9 percent) language or cognitive barrier. 41 participants (4 percent) preexisting dysphagia or dysphonia. 39 participants (4 percent) expected extubation. 37 participants (4 percent) connective tissue or neuromuscular disorder. 33 participants (3 percent) tracheostomy prior to enrollment. 23 participants (2 percent) anatomical abnormalities of upper airway. 19 participants (2 percent) prior endotracheal tube greater than 24 hour within 3 hours. 8 participants (1 percent) incarcerated. 6 participants (1 percent) nasal endotracheal tube. 4 participants (1 percent) pregnant. Step 2. Eligible participants (n equals 292). In step 2, 185 participants which is 63 percent did not enroll. The breakup of the participants who did not enroll is as follows. 89 participants (30 percent) consent declined. 70 participants (24 percent) physician declined study. 26 participants (9 percent) no legally authorized representative. Step 3. 107 participants (37 percent) enrolled. In step 3, 24 participants (22 percent) withdrew from the study. The breakup of the participants who withdrew is as follows. 8 participants (33 percent) died in hospital. 7 participants (29 percent) patient declined scope. 7 participants (20 percent) medically inappropriate for scope. 2 participants (8 percent) other. 3 participants (3 percent) attempted to scope (FNL partially completed). The breakup is as follows. 1 participant (1 percent) scope malfunction. 1 participant (1 percent) patient agitated. 1 participant (1 percent) inability to visualize airway structures. Step 4. 80 participants (75 percent) (FNL fully completed).

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Flow diagram of study enrollment. Flowchart illustrating the process of study enrollment, including the total number of participants assessed for eligibility, reasons for exclusion, and the final number of participants included in the study. Each stage of the enrollment process, from initial assessment to study completion, is detailed with accompanying numerical values to provide a clear overview of participant flow throughout the study.

Characteristics of eligible patients who did versus did not receive FNL (n = 80 vs. n = 27) are reported in Table 2, with median (interquartile range [IQR]) age of 60 (50, 64) versus 61 (50, 68) years (p = .39) and 44% versus 41% female (p = .79), respectively. The majority of patients in both groups were White (61% vs. 63%), with the percentage of Black/African American participants higher in the FNL group (35% vs. 19%). BMI, severity of illness scores, source and type of admission, and primary admitting diagnoses are presented in Table 2. Approximately 40% of patients were transferred from another hospital. A higher proportion of patients in the FNL group were admitted for elective or same-day surgery (19% vs. 4%) and for medical reasons (74% vs. 59%). Mechanical ventilation duration and ICU and hospital lengths of stay were similar between both groups (see Table 2).

Table 2.

Participant demographics and characteristics.

Demographics Laryngoscopy not attempted
(n = 27)		 Laryngoscopy completed
(n = 80)		 p value
Age, years 60 (50–64) 61 (50–68) .39
Sex, female 11 (41) 35 (44) .79
Race White 17 (63) 49 (61) .02
Black or African American 5 (19) 28 (35)
Asian 2 (7) 0 (0)
Prefer not to say 0 (0) 1 (1)
Unknown 3 (11) 2 (3)
Patient characteristics at time of admission
Body mass index (kg/m2) 30 (26–35) 29 (24–36) .88
APACHE II severity of illness score 26 (20–29) 22 (19–29) .44
SOFA score 12 (9–13) 10 (8–12) .14
Source of admission Emergency department 10 (37) 28 (35) .09
Holding unit/observation unit 1 (4) 0 (0)
Outside hospital 11 (41) 32 (40)
Direct admit 4 (15) 5 (6)
Elective/same-day surgery 1 (4) 15 (19)
Type of admission to ICU Medical 16 (59) 59 (74) .02
Scheduled surgery 3 (11) 14 (18)
Unscheduled surgery 8 (30) 5 (6)
Trauma 0 (0) 2 (3)
Primary admitting diagnosis Respiratory 2 (7) 23 (29) .09
Gastrointestinal 10 (37) 14 (18)
Cardiovascular 5 (19) 12 (15)
Sepsis 4 (15) 9 (11)
Oncology 1 (4) 9 (11)
Other 5 (19) 13 (16)
Clinical course
Duration of mechanical ventilation, days 4 (2–5) 3 (1–6) .82
Length of stay in intensive care unit, days 7 (4–11) 7 (4–13) .87
Length of stay in hospital, days 18 (11–28) 18 (11–31) .77
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Note. p value calculated using Wilcoxon rank sum, chi-square, and Fisher's exact tests, as appropriate. Interval data = reported as median (interquartile range); categorical data = reported as counts (percentage); APACHE = Acute Physiology and Chronic Health Evaluation; SOFA = Sequential Organ Failure Assessment; ICU = intensive care unit; CAM-ICU = Confusion Assessment Method–Intensive Care Unit.

Feasibility of Completing FNL

Among the 107 patients enrolled in the study, FNL was Fully Completed for 80 (75%) patients with consents obtained from 74 (92%) LARs and six (8%) patients. Among the remaining 27 patients, FNL was Not Attempted for 24 (89%) patients because they were not eligible for the procedure, with the most common reason being the patient dying/death before FNL (see Figure 1). Seven patients declined the scope after their LAR had initially provided informed consent. There were three patients for whom FNL was only Partially Completed due to (a) equipment malfunction, (b) patient agitation, or (c) inability to visualize airway structures due to the presence of secretions or blood clots.

Feasibility of Completing YSP

Among 80 patients with FNL, a YSP was completed for 66 (83%) patients; an SLP was present for 41 (51%) patients. The presence of SLP was reported by the study proceduralists (nurse practitioner or SLP) to facilitate the successful completion of YSP. This facilitation stemmed from the SLPs' expertise in swallowing evaluation and their ability to provide hands-on assistance, which addressed clinical needs and supported the workflow. Reasons for not completing a YSP included physician or advanced practice provider decline (6%, n = 5), patient decline (10%, n = 8), or vocal fold paralysis (1%, n = 1). Among the patients evaluated, nine (11%) had aspiration directly observed during FNL, while 10 (15%) exhibited coughing during the water swallow test, a clinical sign suggestive of aspiration. However, aspiration was not confirmed in these 10 patients through concurrent FNL visualization. Across all FNLs and YSPs, there were no safety concerns or events.

Timing, Duration, and Clinical Parameters of FNL

The median (IQR) time from extubation to FNL was 10 (8, 12) hr, with 29 (35%) patients scoped within 24 hr of extubation. The RASS sedation scores indicated that most patients were “alert and calm” (RASS 0; 54%, n = 40) followed by “not fully alert, sustained awakening to voice, eye opening & contact for >10 s” (RASS −1; 38%, n = 28) when they were approached for FNL. Two patients exhibited “restlessness” with “anxious, apprehensive, movements not aggressive” (RASS +1), while four patients “briefly awakened to voice with eye opening and contact for < 10 s” (RASS −2). There was only one patient who screened positive for delirium (i.e., CAM-ICU positive). The median duration of FNL was 8.4 (5.5, 13.5) min. Among patients for whom a FNL was completed, the median SOFA score at the time of scope was 4 (2, 7). The median pain rating for FNL was 2 (0, 4) of 10.

Discussion

Our study demonstrated the feasibility of conducting FNL in the setting of a research protocol in critically ill adults. Among enrolled patients, 75% had a fully completed FNL, with death or medical inappropriateness being the most common reasons for FNL that was either not attempted or partially completed. The presence of an SLP during the procedure was noted by the research team as a facilitator of YSP completion, providing additional expertise and practical support to ensure successful execution of this critical evaluation. The YSP was successfully completed during the FNL in 83% of patients.

The ongoing parent study for this evaluation focuses on the assessment of laryngeal anatomy and function post-extubation, with a goal of helping establish data for future clinical guidance, as emphasized in recent publications (Kelly et al., 2023; Krisciunas et al., 2020; Macht et al., 2012; Marvin et al., 2019; Plowman et al., 2021, 2023; Shinn et al., 2019; Skoretz et al., 2017, 2020; Suiter & Leder, 2008; Suiter et al., 2014).

In terms of the feasibility of completing FNL, significant differences emerge when comparing our study with prior publications. In another feasibility study conducted on cardiovascular surgical patients who were intubated for over 48 hr, the FNL full completion rate was 7.7% (Skoretz et al., 2017). Our higher frequency of successful FNL full completion (75%) may be attributed to differences in institutions or patient populations, such as diverse patients from six medical and surgical ICUs versus a single cardiovascular surgery ICU, and variations in inclusion criteria, with our study encompassing patients intubated for over 8 hr compared to over 48 hr of mechanical ventilation.

No clinical pathway for swallowing screening and/or assessment exists in many ICUs, and execution of nurse and/or SLP screenings and evaluations are not consistent across institutions (Brodsky et al., 2014; Macht et al., 2013). However, some algorithms have been proposed (Likar et al., 2023; Moss et al., 2020; Zuercher et al., 2020). In clinical practice, it is common for delays of > 24 hr post-extubation for completing swallowing screening (Leder et al., 2019; Macht et al., 2013; Marvin et al., 2019; Troll et al., 2023). Such delays occur despite some hospitals requiring SLP referrals to be completed within 24 hr. In clinical practice, delays in completing swallowing evaluations post-extubation can arise from two main factors: a perceived need to wait for patient stability or readiness before ordering FNL and logistical lapses between identifying the need for evaluation and completing the SLP referral or procedure. Such delays are particularly concerning given that oral feeding has already been delayed during intubation, contributing to upper aerodigestive tract weaknesses and altered sensation (Brodsky et al., 2018; Su et al., 2015). This study provides empirical evidence that the majority of patients were able to complete FNL < 24 hr from extubation and tolerate the procedure well without medications. These findings align with prior research by Leder et al. (2019), which demonstrated the feasibility of completing FEES at earlier intervals (e.g., 2, 4, and 24 hr post-extubation; Leder et al., 2019). While our study focuses on FNL conducted within a research protocol rather than routine clinical practice, Leder's work highlights the importance of early post-extubation evaluations, supporting the potential clinical and research value of timely assessments. These data are further supported by prior studies as well (Johnson et al., 2018; Leder et al., 2019; Marvin et al., 2019; Plowman et al., 2023; Schefold et al., 2017; See et al., 2016) and help contradict some current clinical practice that may delay such assessments.

The willingness of patients to participate in research studies can be influenced by various factors, including the complexity of their medical conditions and their overall perception of such studies and research personnel (Burns et al., 2013; Labruyere et al., 2022). Additionally, patients may harbor concerns related to research, particularly in the context of medical settings and involving the completion of invasive procedures. In our study, 63% of eligible patients were not enrolled primarily due to patient declining participation (30%), physicians declining access (24%), and inaccessibility of LARs (9%). In addition, after enrollment, 52% (13 of 25) of consented patients did not complete the FNL due to unforeseen medical complications, such as increased oxygen requirements and low platelet counts. Similarly, others have reported challenges with enrollment that included resource constraints, patient declining consents, safety issues, and medical status changes (Krisciunas et al., 2020). Participant declining participation, intolerance, medical complications, and technical/equipment issues also played a role in not completing FNL (Krisciunas et al., 2020). These challenges exemplify the unpredictable nature of critical illness, as highlighted in previous studies (Lehman et al., 2012). Understanding these issues can provide insights into optimizing recruitment and completion rates in future studies employing FNL in the ICU.

Our study included 107 adult ICU patients who were mechanically ventilated in an ICU for ≥ 8 hr, 11% of whom exhibited observed aspiration. This finding is lower when compared to the 32% frequency in a study that evaluated swallowing function in 210 adult ICU patients who were mechanically ventilated > 48 hr (Krisciunas et al., 2020). The longer duration of intubation in the prior publication may have played a role in the increased frequency of dysphagia and aspiration (Krisciunas et al., 2020; Leder et al., 2019; Macht et al., 2012; Marvin et al., 2019; Plowman et al., 2023).

In our study, 25% of enrolled patients did not undergo FNL, highlighting barriers to participation and protocol feasibility. The most common barrier was patient mortality prior to the procedure, a nonmodifiable factor. Informed consent for this research protocol also posed challenges; while LARs often provided consent on behalf of incapacitated patients, these data demonstrate that LARs are not always perfect proxies for patient wishes. Therefore, we always sought to reobtain consent—or at least assent—from patients directly once they regained capacity, ensuring respect for their autonomy. Other barriers included medical contraindications that made the procedure inappropriate due to patient instability, as well as rare procedural challenges such as equipment malfunction, patient agitation, and issues with visualizing airway structures due to preexisting bloody secretions. These findings highlight the need for research protocols that are flexible and ethically robust, accommodating the fluctuating conditions and preferences of patients to uphold both study integrity and participant welfare.

Limitations

While this report provides important insights, it also has limitations. First, although recruiting from six different ICUs, this research was conducted in a single institution, limiting the generalizability of our findings. Future studies should involve multiple institutions. Second, our study was limited to patients who were eligible for FNL after ≥ 8 hr of intubation in an ICU and assessment within 72 hr of extubation, which may also influence generalizability. Third, our study experienced declined consent or participation, introducing possible selection bias. Addressing these challenges is an important consideration for participant recruitment and retention in future studies. Finally, it should be noted that the eligibility criteria in this research protocol were chosen to balance generalizability and pragmatics of research (i.e., sufficient timing and coordination of research procedures). While these criteria were appropriate for the study's research objectives, they may not fully capture the complexities encountered in clinical practice, where decision making involves a more comprehensive assessment of patient factors and individual circumstances. Hence, the eligibility criteria may not directly translate to clinical practice due to the nuanced considerations involved. Moreover, some of the challenges and barriers faced during this research study may not be present during clinical practice.

Conclusions

Our study provides empirical evidence that FNL can be safely completed, within the context of a research protocol, with adult patients who were mechanically ventilated. These data demonstrate a notable success rate and support that FNL is well tolerated without the use of any topical or intravenous medications. Our study contributes to the existing body of knowledge on post-extubation laryngeal injury by demonstrating the feasibility of FNL, as part of a research protocol, in adult patients post-extubation after mechanical ventilation in medical and surgical ICUs. Further research should consider the issues raised in this report and in prior studies when planning study protocols.

Author Contributions

Vinciya Pandian: Conceptualization, Funding acquisition, Investigation, Data curation, Formal analysis, Supervision, Writing – original draft, Writing – review & editing. Sai Phani Sree Cherukuri: Project administration, Data curation, Formal analysis, Writing – original draft, Writing – review & editing. Mounica Koneru: Project administration, Data curation, Writing – review & editing. Gowthami Sai Kogilathota Jagirdhar Reddy: Project administration, Data curation, Writing – review & editing. Pooja Kota: Project administration, Data curation, Formal analysis, Writing – review & editing. Victor D. Dinglas: Data curation, Formal analysis, Writing – review & editing. Elizabeth Colantuoni: Formal analysis, Writing – review & editing. Lee Akst: Data curation, Writing – review & editing. Alexander T. Hillel: Data curation, Writing – review & editing. Dale M. Needham: Conceptualization, Funding acquisition, Project administration, Investigation, Data curation, Supervision, Writing – review & editing. Martin B. Brodsky: Conceptualization, Funding acquisition, Project administration, Investigation, Data curation, Supervision, Writing – original draft, Writing – review & editing.

Data Availability Statement

Data supporting the results reported in this technical report are available upon reasonable request from the corresponding author.

Acknowledgments

PALSS Study Team: Darin Roberts: MD, Research Coordinator, Paley Orthopedic and Spine Institute, West Palm Beach, FL, darin.roberts@gmail.com. Naga Preethi Kadiri: Resident, Family Medicine, Honor Community Health, MI, Preethi.kadiri@gmail.com. Parvaneh Vaziri: MD, MSc, Resident, Family Medicine Residency Program, PIH Health Downey Hospital, Downey, CA, parvanehvaziri@gmail.com. Roozbeh Nikooie: MD, Resident, University of Massachusetts School of Medicine, Division of Cardiology, Worcester, MA, roozbeh.nikooie@googlemail.com. Swetha Aloori: MBBS, Postdoctoral research fellow, Outcomes After Critical Illness and Surgery (OACIS) Research Group, Johns Hopkins University, Baltimore, MD, saloori1@jhmi.edu. Vishwanath Thondamala: MBBS, Resident, Department of Family Medicine, LSU Health Shreveport, Monroe, Los Angeles, CA, visu.medico@gmail.com.

This study was funded by Grants NIH/NINR R01NR017433 and R01NR017433-01A1 (awarded to Principal Investigators: Martin B. Brodsky, Dale M. Needham, and Vinciya Pandian). We would like to express our deepest gratitude to the patients and their family members who participated in this study. Without their willingness to participate, this research would not have been possible. We also extend our appreciation to the dedicated nurses who provided care to these research patients and helped facilitate integrating the research team into clinical care. Additionally, we would like to acknowledge the invaluable contribution of the speech-language pathologists who provided their expertise in the evaluation and treatment of our participants. Finally, we would like to thank all of the individuals who supported this study in various capacities, including data collection, analysis, and manuscript preparation.

Funding Statement

This study was funded by Grants NIH/NINR R01NR017433 and R01NR017433-01A1 (awarded to Principal Investigators: Martin B. Brodsky, Dale M. Needham, and Vinciya Pandian).

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

Data supporting the results reported in this technical report are available upon reasonable request from the corresponding author.

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