Perioperative management protocol for pediatric endoluminal functional lumen imaging probe in esophageal motility disorders

Abstract

Objectives:

Lower esophageal sphincter achalasia is associated with a higher risk of aspiration during anesthesia. Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is used as an adjunctive tool in both the diagnosis and treatment of achalasia, for which all children require anesthesia. Anesthesia may affect the parameters of the EndoFLIP due to its effect on gut motility. There are no standard anesthesia protocols to help decrease the risk of aspiration and the undesirable effect of anesthesia on EndoFLIP parameters. This study aims to standardize an anesthesia protocol to target both goals.

Methods:

A protocol was developed to address perioperative management in patients undergoing EndoFLIP for any indication to minimize both anesthetic effect on the esophageal motility as well as perioperative complications. A retrospective data analysis was conducted on patients who underwent EndoFLIP at Cincinnati Children’s Hospital Medical Center; pre- and post-protocol implementation data including adverse events was compared.

Results:

Pre-protocol implementation: 60 cases (median age of 13.8 years, 30 [50%] females) with 2 cases of adverse events (3.3%). Post-protocol implementation: 71 cases (median age of 14.6 years, 37 [52.1%] females) with no adverse events (0/71 = 0%). In comparison between pre- and post-protocol cases, no significant difference was noted in gender, age, and adverse events. Post-protocol procedures were found to be significantly shorter (median time of 89 vs. 79 min, p = 0.004).

Conclusions:

Our anesthesia protocol provides a standardized way of administering anesthesia minimizing impact on EndoFLIP parameters and aspiration for patients with achalasia.

Graphical Abstract

1 |. INTRODUCTION

Achalasia of the lower esophageal sphincter (LES) is associated with a higher risk of aspiration, especially during sleep, sedation, and under anesthesia.¹ This is primarily due to impaired clearance of esophageal contents combined with obtundation of airway protective reflexes in these states. Endoluminal Functional Lumen Imaging Probe (EndoFLIP) technology is being increasingly used in adults and children to confirm and diagnose achalasia, as well as assess the success of interventions including pneumatic balloon dilation, and surgical or endoscopic myotomy.^2,3 In adults, EndoFLIP can be performed under sedation, but in children, general anesthesia is used to accomplish this during endoscopy. Since EndoFLIP assesses the biomechanical properties of the smooth muscle, it is imperative that the anesthetic agents used do not affect the function of the smooth muscle of the esophagus and LES.

Previous publications demonstrate that EndoFLIP measurements might be affected by anesthesia.⁴ There are published reports of anesthetic agents and adjuvant therapy administered during anesthesia affecting the motility of the gastrointestinal tract (GIT).^5,6 Inhalational anesthetic agents in particular are notable for inducing GIT dysmotility.⁷ Currently, there is no consensus on the most appropriate anesthetic management for children with a history of achalasia and those having an EndoFLIP procedure.

We aimed to develop a protocol to prevent perioperative complications in children with achalasia undergoing sedation and general anesthesia, as well as minimize the effect of anesthesia on the GIT motility during EndoFLIP procedure.

2 |. DESIGN AND METHODS

The neurogastroenterology faculty at Cincinnati Children’s Hospital Medical Center (CCHMC) collaborated with faculty of the Department of Anesthesia to develop guidelines to provide a safe perioperative experience and prevent aspiration and other complications in children with achalasia. Additionally, the team worked on an anesthesia protocol to be employed when performing EndoFLIP that would avoid having an impact on smooth muscle function.

The team performed an extensive literature review on the pharmacodynamics of different anesthetic agents and other medications commonly used during anesthesia and their effect on esophageal motility. This included adjuvant agents like pain medications and antiemetics. After several review meetings, a draft was prepared which was presented at a general meeting of anesthesiologists, with over 30 attendants. The reasons for including or excluding agents and the need for specific interventions during pre-, intra, and postoperative periods were discussed at length. After a consensus was reached, the draft was finalized for execution on the first five cases to gauge its operational feasibility and safety. The finalized draft of the document was circulated and discussed with the perioperative staff. The anesthesiology team was asked to report their experience after completion of the cases to the lead anesthesiologist and the neurogastroenterologists reported the outcome of the EndoFLIP procedure to the lead neurogastroenterologist. The perioperative staff also communicated their observations to the team. After completion of the first five cases, the team met to discuss the surveys. Minor preoperative issues with incongruent parental instructions regarding oral intake and unclear communication regarding the need to suction the esophagus while awake in the endoscopy suite were reported. No other major concerns were expressed by the anesthesiology, gastroenterology, or perioperative teams after completion of the first five cases and the protocol was finalized.

The final combined protocol for EndoFLIP/achalasia (see Figure 1) included guidelines for preoperative as well as intraoperative measures to be taken to minimize aspiration risk as well as help obtain accurate EndoFLIP readings, thus improving patient care and outcome. This final protocol was shared extensively through a series of educational lectures to the perioperative staff to familiarize them with the final protocol as an effort to mitigate the increased risk of complications like aspiration in patients with achalasia and to get meaningful results using EndoFLIP technology. The final iteration of the protocol was also shared with the gastroenterology providers and nursing staff in a series of meetings.

FIGURE 1.

Pediatric EndoFLIP/achalasia anesthesia protocol. Created with BioRender.com. GI, gastrointestinal; IV, intravenous.

After the protocol was approved, the leadership team implemented the protocol in the perioperative area. Initially, the GI team was in charge of notifying same day surgery (SDS) via email when to activate the “Achalasia Protocol,” as well as educating the families on special nil per os (NPO) instructions and what would occur once they arrived in SDS. Preoperative protocol was handled by the preoperative nursing team and included close patient monitoring until the intravenous (IV) was in place and glucose measurement was taken and reported as normal due to the prolonged NPO time.

We partnered with our electronic medical records “EPIC” team to incorporate the protocol in EPIC. A safety note was created by anesthesia and GI that would alert the need for an anesthesia consult before anesthesia and sedation. The safety note would be applied to any patient with an Achalasia diagnosis by the GI team, even when coming for surgical procedures other than endoscopy and EndoFLIP. The safety note showed up as an “advisory note” to any EPIC user when opening the EPIC chart.

In efforts to have a more reliable system for preoperative team awareness of what surgical cases required the GI achalasia protocol, a change was made to the EPIC surgical panel verbiage. This eliminated the need for GI team to communicate with the Prep teams. The prep teams would view the EPIC panels before making the pre-op phone call, as well as alert the charge team of the cases on the day of the procedure.

The protocol was approved by Cincinnati Children’s Hospital Medical Center Institutional Review Board (CCHMC IRB) tool. A retrospective data collection was performed for all patients who underwent EndoFLIP at CCHMC in Cincinnati, OH, from January 2018 to June 2023. This included the pre-protocol period from January 2018 to October 2020, and post-implementation period from November 2020 to June 2023. Data collected included demographic information, indications for and the date of study, and comorbidities. Outcome variables included the length of procedure and adverse events (change in vital signs intraoperatively that required intervention, perioperative aspiration, perioperative anesthesia complications, and the need for unplanned admission postoperatively), including endoscopic adverse events as described in literature per the American Society of Gastrointestinal Endoscopy workshop.⁸ Adverse events were defined as “an event that prevents completion of the planned procedure and/or results in admission to hospital, prolongation of existing hospital stay, another procedure (needing sedation/anesthesia), or subsequent medical consultation.”

The difference between pre and post-protocol management is primarily a difference in the anesthetic drugs administered. Before the protocol, the anesthesiologists were free to administer appropriate drugs at their discretion. Before the protocol, patients at risk for aspiration were routinely intubated. After initiation of the protocol, the anesthetic drugs were limited to the drugs on the protocol.

2.1 |. Data collection

Data were collected from electronic medical records and the digital manometry database at CCHMC. Data were deidentified before publication and reported as sample statistics.

2.1.1 |. Inclusion criteria

All children had an EndoFLIP procedure performed to evaluate esophageal motility disorder, including tight fundoplication and esophageal strictures.

2.1.2 |. Exclusion criteria

Patients with no history or suspected achalasia and no EndoFLIP performed.

The study protocol was approved by the institutional review board (approval number 2023–0340).

Demographic and other clinical characteristics are summarized and compared between Pre and Post-protocol groups. Continuous variables are presented as means ± standard deviations for normally distributed variables, and as medians with interquartile ranges (IQRs) for non-normally distributed variables. Comparisons are made either with two-sample t test or Wilcoxon test. Qualitative or categorical variables are expressed as numbers and proportions and compared with Fisher’s exact test.

3 |. RESULTS

The demographics of our cohort are shown in Table 1. Common indications for EndoFLIP were achalasia, eosinophilic esophagitis, and other dysphagia including fundoplication.

TABLE 1.

Patients’ characteristics before and after the implementation of the protocol.

	Pre-protocol (n = 60)	Post-protocol (n = 71)	p Value
Gender, female, n (%)	30 (50%)	37 (52.1%)	0.86
Age, median years (IQR)	13.8 (10.6–18.3)	14.6 (10.6–17.7)	0.8
Diagnosis			0.11
Achalasia, n (%)	11 (18.3%)	20 (28.2%)
Eosinophilic esophagitis, n (%)	6 (10%)	12 (16.9%)
TEF/stricture, n (%)	13 (21.7%)	5 (7%)
EGJOO, n (%)	3 (5%)	3 (4.2%)
Other dysphagia,a n (%)	27 (45%)	31 (43.7%)
Procedural time, median min (IQR)	89 (78–116)	79 (53–94)	0.004
Adverse events, n (%)	2 (3.3%)	0 (0%)	0.21

Abbreviations: EGJOO, esophagogastric junction outlet obstruction; IQR, interquartile range; TEF, tracheoesophageal fistula.

^aNonparametric test was performed.

3.1 |. Pre-protocol implementation

We reviewed 60 cases with a median age of 13.8 years (IQR: 10.6–18.3) and 30 (50%) females. Two cases had adverse events during EndoFLIP. One patient had a rare adverse anesthesia drug reaction which resolved within a few hours of the procedure. The second patient had multiple episodes of emesis of undigested food material during anesthesia induction with no aspiration (adverse events 2/60 = 3.3%).

3.2 |. Post-protocol implementation

We reviewed 71 cases with a median age of 14.6 years (IQR: 10.6–17.7) and 37 (52.1%) females where EndoFLIP was done for different indications. Seven of those did not follow the protocol guidelines. There were no complications and no aspiration events (adverse events 0/71 = 0%).

In comparison between pre- and post-protocol cases, no significant difference was noted in gender, age, and adverse events.

Post-protocol procedures were found to be significantly shorter (median time of 89 min vs. 79 min, p = 0.004).

4 |. DISCUSSION

EndoFLIP is used as an adjunctive tool to esophageal manometry to diagnose and help in the management of LES achalasia in addition to other esophageal conditions.^2,9 EndoFLIP is valuable in providing a more accurate diagnostic evaluation, enhancing the selection of appropriate interventional procedures, and facilitating postoperative assessments. Since patients with achalasia have distal esophageal obstruction, they are at a higher risk for aspiration.^1,10 Therefore, preoperative and intraoperative precautions are important to prevent serious complications, most importantly aspiration pneumonia.

We offer our tested protocol with the potential to reduce the risk of perioperative adverse events and procure relevant information for better outcomes in patients with achalasia and those who are undergoing EndoFLIP procedures. EndoFLIP-related literature currently does not propose a standardized anesthesia protocol. This is crucial, as EndoFLIP is a unique motility diagnostic modality where the metrics are obtained intraoperatively, thus being sensitive to medication administered during the procedure that may have an effect on esophageal motility parameters.^7,11–20 Implementation of a universal protocol will enable the standardization of reported results globally among pediatric patients undergoing EndoFLIP.

At CCHMC, we developed a protocol that considers preoperative, operative (including anesthesia), and postoperative management of patients undergoing EndoFLIP, the majority of which have or are suspected to have achalasia. We implemented the protocol in November 2020 to help optimize the results of our studies and therefore patient care and treatment outcome. Highlights of the protocol include preoperative management with a longer than normal NPO time as well as esophageal suctioning when the patient is awake before rapid sequence induction of anesthesia and intubation to prevent aspiration. Intraoperative management focuses on using anesthetic drugs that have a minimal and brief effect on esophageal motility.²¹ Midazolam was not used for concern for potential effect on esophageal motility as some reports in literature showed mixed data.¹⁶ The protocol includes rapid sequence induction with rocuronium or succinylcholine only (no sevoflurane, no narcotics, no benzodiazepines, no IV lidocaine as they have been shown to impact esophageal peristalsis and LES pressure) to facilitate intubation and minimize risk of aspiration, followed by the initiation of propofol infusion at 200 mcg/kg/min and low dose remifentanil infusion at 0.2 mcg/kg/min for maintenance of anesthesia avoiding propofol boluses to minimize its effect on the esophageal motility.^{12–15,18,22–24} Sugammadex is given to reverse muscle relaxation before EndoFLIP. If succinylcholine is used, its effect is typically less than 10 min.²⁵ Then, documentation of full return of neuromuscular function is done before the EndoFLIP using a Twitch monitor.

Once the EndoFLIP procedure is complete, the anesthesiologist can administer any drugs as indicated with no restrictions (e.g., inhaled anesthetics, narcotics, and anti-emetics including Ondansetron) apart from ketorolac to avoid excessive bleeding after esophageal dilation.^19,20 The lack of adverse events after protocol implementation is statistically not significant but reassuring. A shorter procedure time of more than 10% was noted after the implementation of the protocol. This is possibly related to a standardized anesthesia protocol, or secondary to the experience acquired in the use of EndoFLIP among the providers.

5 |. CONCLUSION

Our anesthesia protocol provides a standardized anesthetic process that does not adversely impact EndoFLIP measurements, thus helping to provide optimal clinical management. The protocol is also designed to optimize patient safety and minimize complications before, during, and after EndoFLIP procedures.

What is Known.

• Achalasia is associated with a higher risk for aspiration during anesthesia.

• Management of achalasia includes the use of Endoluminal Functional Lumen Imaging Probe (EndoFLIP) during diagnosis and treatment.

• Multiple drugs used during anesthesia can impact EndoFLIP parameters.

• There are no guidelines for anesthesia protocols to minimize aspiration risks and optimize EndoFLIP parameters for achalasia patients.

What is New.

• A proposed anesthesia protocol for children with achalasia undergoing EndoFLIP.

• Results of a collaborative effort between gastrointestinal and anesthesia to optimize implementation of the protocol- pediatric referral center experience.

• Proposed guidelines may facilitate standardization of achalasia/EndoFLIP anesthesia protocols to minimize complications, optimize management, and provide a format for further research.