Abstract
Background and Aims:
The endotracheal tube (ETT) is commonly used in mechanically ventilated patients to allow for proper ventilation and prevent aspiration of gastropharyngeal contents. Adequate sealing pressures are required to prevent aspiration while being low enough to maintain adequate perfusion of the tracheal mucosa. Multiple techniques exist for inflation of the endotracheal cuff. This study evaluated and compared four different cuff inflation techniques with the primary objective of measuring the volume of air needed to create an effective seal.
Methods:
After ethical approval and trial registration, 240 patients scheduled for surgery under general endotracheal tube anaesthesia were enroled, and 228 patients were randomised into four groups (n = 57 per group). The ETT cuff was inflated with air according to the designated group. The techniques were compared for the volume of air required to achieve an adequate seal, cuff pressure post-intubation and just before extubation, cuff-related complications of sore throat, hoarseness of voice, and cough after extubation.
Results:
The manual palpation technique had the highest cuff volume, 5.7 mL [interquartile range (IQR): 5.6–5.8], and cuff pressure after inflation, 29.5 (IQR: 29.1–29.9, cmH₂O), whereas the pressure–volume loop (PVL) method had the lowest values [4.3 (IQR: 4.2–4.3) mL; 23.0 (IQR 22.7–23.4) cmH₂O] (P < 0.001). Before extubation, Group 4 (manual palpation) again recorded the highest cuff pressure [31.3 (IQR: 30.9–31.8) cmH₂O] and cuff volume [6.0 (IQR: 5.9–6.1) mL], while the PVL group had the lowest values [24.9 (IQR: 24.6–25.2) cmH₂O; 4.6 (IQR: 4.6–4.7) mL] (P < 0.001).
Conclusion:
Cuff inflation guided by the PVL method effectively maintained ETT cuff pressures and volumes within acceptable limits.
Keywords: Airway complications, airway pressures, cuff pressure, endotracheal tube cuff inflation, manual palpation, mechanical ventilation, pressure–volume loop
INTRODUCTION
General anaesthesia, along with controlled ventilation with the help of endotracheal intubation, is a popular technique used for different surgical procedures.[1] A cuffed endotracheal tube (ETT) is commonly utilised for mechanically ventilated patients, ensuring adequate lung ventilation and preventing aspiration of gastropharyngeal contents.[2] While the ETT cuff pressure should be high enough to achieve a proper seal, prevent aspiration of collected secretions, and minimise air leaks around the tube, at the same time, it should be low enough for sufficient perfusion of the tracheal mucosa.[2] Studies support that the minimum occlusive intra-cuff pressure to prevent aspiration and reduce the chances of ventilator-associated pneumonia (VAP) during positive pressure ventilation is approximately 20 cm of H2O.[2] Hence, a narrow range of 20 to 30 cm of H2O of cuff pressure is recommended.[2,3]
Multiple techniques exist for the inflation of the endotracheal cuff, such as the manual palpation of the pilot balloon (MP), passive release (PR), inflation to precise pressure, that is, 25 cm H2O (IPP), and the pressure–volume loop (PVL) technique. The adequacy of the seal is checked by many anaesthesiologists by manual palpation of the ETT pilot balloon, felt as tight enough, which refers to the cuff pressure. However, this does not correlate well with the cuff pressure measured by a manometer.[4,5]
The minimum occlusive volume (MOV) technique is done by filling the cuff with minimum increments of air until no air leakage is detected. However, it has been reported that a further addition of around 0.5 mL of air or increasing the cuff pressure by around 4 cm H2O is required for complete occlusion.[6] Another technique employed for inflating the ETT cuff is the PVL technique. The anaesthesia workstation and mechanical ventilator monitoring systems incorporate PVL graphics, providing real-time pulmonary graphic data. It can also detect air leaks and over-inflation of lungs and assess dynamic lung compliance.[7,8]
The literature is ambiguous regarding the ideal technique to check the adequacy of ETT cuff pressure with an appropriate air volume. Also, after reviewing the literature, we noted that no study has compared the four techniques of cuff inflation. This study evaluated and compared four different cuff inflation techniques with the primary objective of measuring the volume of air needed to create an effective seal. The secondary objectives were to measure the resulting intra-cuff pressure and the incidence of complications related to the cuff. We hypothesise that the ETT cuff pressure and the volume of air required to inflate the cuff will be comparable among the four techniques.
METHODS
The randomised study was conducted at a tertiary institute after approval from the Institutional Ethics Committee (vide approval number IEC/AIIMS/BTI/294 dated 16.11.22) and registered with the Clinical Trials Registry – India (CTRI/2023/06/054102 dated 19.06.2023, accessible at www.ctri.nic.in/). The study was conducted from June 2023 to March 2024 and adhered to the principles outlined in the Declaration of Helsinki (2013) and Good Clinical Practice guidelines. Written informed consent has been obtained for participation in the study and use of the patient data for research and educational purposes. The manuscript follows the Consolidated Standards of Reporting Trials (CONSORT) statement.
The study assessed and compared the PVL, IPP, minimum occlusive volume, and manual palpation techniques concerning the volume of air required to achieve an adequate seal, intra-cuff pressure, and airway morbidity. Two hundred forty adult patients between 18 and 65 years, with American Society of Anesthesiologists (ASA) physical status I to III, and scheduled for elective surgery under general endotracheal tube anaesthesia, were enroled and randomised into four groups. Patients with a body mass index (BMI) >35 kg/m2, with a risk of pulmonary aspiration, or with an anticipated difficult airway; patients undergoing airway surgeries and head and neck surgeries; the use of a throat pack during surgery; and parturients were excluded from the study. Patients were randomly allocated to one of the four groups using a computer-generated random number list (https://www.randomizer.org/) with group allocation in sequentially numbered, sealed, opaque envelopes. The sealed envelope was handed over to the anaesthesiologist performing the endotracheal intubation, and cuff inflation was done according to the assigned group. The participants and the anaesthesiologist recording the data were unaware of the technique of cuff inflation used.
All the selected subjects meeting the inclusion criteria were fasted for 6 hours preoperatively. Upon arrival in the operating room, patients were placed supine, standard ASA monitors attached, and the baseline vital parameters were noted. Intravenous (IV) midazolam 1 mg, fentanyl 2 µg/kg was administered as pre-medication. Pre-oxygenation was done with 100% oxygen by facemask, and general anaesthesia was induced using IV propofol 1.5–2.5 mg/kg. After checking the ability to ventilate via bag and mask, IV vecuronium 0.1 mg/kg was administered to facilitate tracheal tube insertion. Lungs were ventilated with an oxygen–air mixture (50:50) and isoflurane to deepen the plane of anaesthesia. The tracheal tube was checked and lubricated with water-based gel. Under direct laryngoscopy in sniffing position, tracheal intubation was performed using a cuffed polyvinyl chloride (PVC) ETT sized 7.0 mm ID and 8.0 mm ID in females and males, respectively. The cuff was inflated with air according to the designated group using a Luer lock syringe.
In Group 1 (Pressure–Volume Loop Technique, PVL), the ETT cuff was initially inflated with 2 mL of air, followed by incremental additions of 0.2 mL using a 2 mL syringe. Inflation continued until complete closure of the PVL was observed on the Avance CS2 anaesthesia workstation monitor—specifically, when the expiratory limb returned to zero volume and intersected with the starting point of the inspiratory limb. In Group 2 (Inflation to Precise Pressure, IPP), the ETT cuff was inflated to a target pressure of 25 cm H₂O, which was verified using an aneroid manometer to ensure accuracy. In Group 3 (Minimal Occlusive Volume Technique, MOV), the cuff was initially inflated with 2 mL of air, followed by 0.2 mL increments using a 2 mL syringe. Inflation was continued until no audible air leak was detected during auscultation over the trachea. In Group 4 (Manual Palpation Technique, MP), the cuff was inflated with 5 mL of air using a 5 mL syringe connected to a three-way valve. Adequacy of cuff inflation was assessed by palpating the pilot balloon. The valve was locked to maintain cuff pressure once an acceptable seal was confirmed via manual palpation.
Once an adequate seal was obtained, the volume of air required for cuff inflation and the corresponding intracuff pressure were documented. Cuff pressure measurements were repeated after 1 hour and/or after surgery, whichever occurred later. Before extubation, the volume of air withdrawn to achieve complete deflation of the ETT cuff was recorded. A standardised scoring system was employed to assess postoperative sore throat, cough, and hoarseness of voice at 30 minutes and 24 hours.[9]
The sample size was calculated according to the formula given by Snedecor, G W and Cochran W G (Statistical Methods. 8th Edition, Iowa State University Press, Ames. 1989), based on a study by Almarakbi et al.,[7] who reported the median and quartiles of the volume of air as 4.05 ml [standard deviation (SD): 0.59]. Sample size 
, where σ (SD = IQR/1.35) = 0.593 and δ (difference to detect) = a sample size to detect a minimum clinically important difference (MCID) as low as 0.2. Type I error (α) = 0.8333333%, Zα (Value of Standard Normal Distribution for α = 0.8333333%) = 2.638 and Type II error (β) = 1%, Power (1 – β) = 99%, Z1-β = 2.326. Thus, based on the mentioned formula, assuming 99% power and 99.16% confidence interval, the minimum calculated sample size is 219. Considering 10% attrition, 240 patients were enroled.
The Microsoft Excel spreadsheet program was used to code and record the data, and statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) Statistics software, version 24.0 for Mac (IBM Corporation, Armonk, NY, USA). Normality of continuous variables (age, height, weight, BMI, haemodynamic parameters, and cuff-related measurements) was checked using the Kolmogorov–Smirnov (K-S) test. Normally distributed data were summarised as mean (SD), while skewed data were presented as median (interquartile range, IQR). Since cuff-related measurements did not follow a normal distribution, they are reported as median (IQR) and compared using the Kruskal–Wallis test. Categorical variables such as gender, ASA physical status, air leak, and post-operative complications were expressed as number (percentage) and analysed using the Chi-square test. Continuous variables between two groups were compared using the independent samples t-test if normally distributed or the Mann–Whitney U test if not normally distributed. When comparing more than two groups, repeated-measures ANOVA with post hoc pairwise analysis was applied for normally distributed data, while the Kruskal–Wallis test was used for non-normally distributed data. A P value <0.05 was considered statistically significant.
RESULTS
A total of 240 patients were screened for eligibility. Twelve patients were excluded (nine did not meet the inclusion criteria, and three declined to participate). The remaining 228 patients were randomised into the four study groups and were included in the final analysis [Figure 1]. Baseline demographic characteristics were comparable among all four groups [Table 1]. Baseline haemodynamic variables were comparable [Table 2]. The volume of air required to inflate the cuff, cuff pressure after inflation, cuff pressure before extubation, and cuff volume before extubation differed significantly across the four groups (P < 0.001) [Table 3]. Group 4 had the highest median cuff volume of 5.71 mL (IQR: 5.6–5.8) and cuff pressures after inflation of 29.47 cmH2O (IQR: 29.1–29.9), while Group 1 had the lowest values [4.3 mL (IQR: 4.2–4.3); 23.0 cmH₂O (IQR: 22.7–23.4)]. On post hoc analysis, there was a significant mean difference between Group 1 and the other three groups (P <0.001) and also between Group 4 and the other groups (P <0.001). The Chi-square test showed a significant difference in air leak after inflation across the four groups (P <0.001). Cuff inflation in Group 3 was associated with the most frequent occurrence of air leakage (35.1%). When the amount of additional air injected was compared, the groups were comparable (P = 0.103) [Table 3]. The cuff pressures and volumes were measured again before extubation. The highest median cuff pressure was 31.3 cm H₂O (IQR: 30.9–31.8); 6.0 mL (IQR: 5.9–6.1) was recorded in Group 4 (P < 0.001). Group 1 had the lowest 24.9 cm H₂O (IQR: 24.6–25.2); 4.6 mL (IQR: 4.6–4.7). On post hoc analysis of cuff pressures and volumes before extubation, there was a significant mean difference in the volume of air required to inflate the cuff and the cuff pressures between Group 1 and the rest of the three groups (P < 0.001) and also between Group 4 and the rest of the three groups (P < 0.001) [Table 4].
Figure 1.
Consolidated Standards of Reporting Trials (CONSORT) flow diagram for participant enrolment
Table 1.
Demographic data of study participants
| Parameter | Group 1 (PVL) (n=57) | Group 2 (IPP) (n=57) | Group 3 (MOV) (n=57) | Group 4 (MP) (n=57) | P |
|---|---|---|---|---|---|
| Age (years), Mean (SD) | 40.26 (13.95) | 38.14 (13.57) | 38.61 (12.86) | 37.40 (12.34) | 0.696 |
| Height (cm) Median (IQR) | 170 (162-172) | 168 (160-172) | 166 (158-172) | 168 (158-175) | 0.669 |
| Weight (kg) Median (IQR) | 68 (64-72) | 68 (65-72) | 66 (60-70) | 70 (65-76) | 0.109 |
| BMI (Kg/m2) Median (IQR) | 23.66 (22.22-25.51) | 24.97 (23.37-27.43) | 24.03 (22.49-25.18) | 24.74 (22.93-26.51) | 0.205 |
Data are expressed as mean (standard deviation) or median (interquartile range). VL=pressure–volume loop; IPP=inflation to precise pressure; MOV=minimal occlusive volume; MP=manual palpation
Table 2.
Baseline haemodynamic parameters
| Parameter | Group 1 (PVL) (n=57) | Group 2 (IPP) (n=57) | Group 3 (MOV) (n=57) | Group 4 (MP) (n=57) | P |
|---|---|---|---|---|---|
| Heart Rate (beats/min), Median (IQR) | 75 (72-83) | 79 (74-86) | 78 (74-84) | 78 (74-82) | 0.133 |
| Systolic BP (mmHg), Median (IQR) | 132 (122-138) | 130 (122-132) | 132 (122-134) | 131 (122-133) | 0.587 |
| Diastolic BP (mmHg), Median (IQR) | 80 (76-84) | 80 (78-84) | 80 (78-82) | 80 (78-82) | 0.995 |
| SpO2(%), Median (IQR) | 99 (99-100) | 100 (99-100) | 100 (99-100) | 100 (98-100) | 0.160 |
Data are expressed as median (interquartile range). VL=pressure–volume loop; IPP=inflation to precise pressure; MOV=minimal occlusive volume; MP=manual palpation; SpO2=oxygen saturation; BP = blood pressure
Table 3.
Cuff inflation and deflation parameters
| Parameter | Group 1 (PVL) (n=57) | Group 2 (IPP) (n=57) | Group 3 (MOV) (n=57) | Group 4 (MP) (n=57) | χ 2 | P |
|---|---|---|---|---|---|---|
| Volume of air to inflate cuff (mL), Median (IQR) | 4.3 (4.2–4.3) | 4.6 (4.6–4.7) | 4.6 (4.5–4.6) | 5.7 (5.6–5.8) | 176.2 | <0.001 |
| Cuff pressure after inflation (cmH2O), Median (IQR) | 23.0 (22.7–23.4) | 25.0 (25.0–25.1) | 25.1 (24.8–25.4) | 29.5 (29.1–29.9) | 175.8 | <0.001 |
| Additional air injected (mL), Median (IQR) | 0.5 (0.4–0.6) | 0.5 (0.4–0.6) | 0.3 (0.3–0.4) | 0.7 (0.6–0.7) | 6.2 | 0.103 |
| Cuff pressure before extubation (cmH2O), Median (IQR) | 24.9 (24.6–25.2) | 27.1 (26.8–27.3) | 27.1 (26.7–27.4) | 31.3 (30.9–31.8) | 168.7 | <0.001 |
| Cuff volume before extubation (mL), Median (IQR) | 4.6 (4.6–4.7) | 4.9 (4.8–4.9) | 4.8 (4.8–4.9) | 6.0 (5.9–6.1) | 161.8 | <0.001 |
Data are expressed as median (interquartile range). VL=pressure–volume loop; IPP=inflation to precise pressure; MOV=minimal occlusive volume; MP=manual palpation
Table 4.
Air leak after cuff inflation
| Air leak | Group 1 (PVL) (n=57) | Group 2 (IPP) (n=57) | Group 3 (MOV) (n=57) | Group 4 (MP) (n=57) | Total (n=228) | χ 2 | P |
|---|---|---|---|---|---|---|---|
| Yes | 10 (17.5%) | 10 (17.5%) | 20 (35.1%) | 3 (5.3%) | 43 (18.9%) | 16.8 | <0.001 |
| No | 47 (82.5%) | 47 (82.5%) | 37 (64.9%) | 54 (94.7%) | 185 (81.1%) |
Values expressed as a number (percentage). PVL=pressure–volume loop; IPP=inflation to precise pressure; MOV=minimal occlusive volume; MP=manual palpation
There was a significant difference in postoperative complications, such as sore throat, hoarseness of voice, and cough, at 30 minutes across the four groups, with higher complaints in Group 4 (P < 0.001) [Table 5]. The PVL group had the lowest sore throat score at 30 min [Table 5]. There was no statistical difference among the four groups regarding the distribution of cough at 24 hours (P = 0.078). Still, the participants of Group 4 had the highest proportion of cough at 24 hours with scores 2 and 3 (P = 0.128).
Table 5.
Comparison of post-operative complications
| Parameter | Group 1 (PVL) (n=57) | Group 2 (IPP) (n=57) | Group 3 (MOV) (n=57) | Group 4 (MP) (n=57) | P | |
|---|---|---|---|---|---|---|
| Sore Throat | 30 min, Median (IQR) | 1 (1–2) | 2 (1–2) | 2 (2–2) | 2 (2–3) | <0.001* |
| 24 h, Median (IQR) | 1 (0–1) | 1 (0–1) | 1 (1–1) | 2 (1–2) | <0.001* | |
| Hoarseness | 30 min, Median (IQR) | 1 (1–2) | 2 (1–2) | 2 (1–2) | 2 (2–3) | <0.001* |
| 24 h, Median (IQR) | 1 (0–1) | 1 (0–1) | 1 (0–1) | 2 (1–2) | <0.001* | |
| Cough | 30 min, Median (IQR) | 1 (0–1) | 1 (1–2) | 1 (1–2) | 2 (1–3) | <0.001* |
| 24 h, Median (IQR) | 1 (0–1) | 1 (0–1) | 1 (0–1) | 1 (1–2) | 0.078 |
Data are expressed as median (interquartile range). PVL=pressure–volume loop; IPP=inflation to precise pressure; MOV=minimal occlusive volume; MP=manual palpation
DISCUSSION
In our study, the four cuff inflation techniques showed differences in performance with respect to cuff volume, cuff pressure, and the occurrence of air leak. The manual palpation method tended to produce higher values, while the PVL technique consistently resulted in the lowest. The MOV and IPP methods fell in between, with broadly comparable outcomes. Air leak was most frequently seen with the MOV technique and least with manual palpation, although the requirement for additional air to achieve an adequate seal was not significantly different. These findings highlight the variability inherent in commonly used methods and provide a reference point for comparison with published literature.
The ETT is designed to secure the airway, prevent aspiration, and enable effective ventilation.[10] Achieving the correct cuff pressure, however, remains challenging as it is influenced by several patient-related and procedural factors including tracheal size, anatomy, head–neck position, tube characteristics, surgical manipulation, and use of nitrous oxide. The technique employed for cuff inflation itself adds another layer of variability.[11]
The method used to inflate the cuff may also lead to considerable variability.[11] Kaki et al.[12] compared the PVL technique, MP technique, and an aneroid manometer controlling a preset cuff pressure (20 cmH2O) in consistency with our study. A study by Almarakbi et al.[7] compared ETT cuff volume and pressure using three sealing methods: manual palpation, a preset cuff pressure of 25 cmH2O, and a sealing method. The ETT cuff inflation volume was significantly lower (P < 0.05) in the sealing group compared to the other two groups, and cuff pressures were highest in the manual palpation group. The results of our study were in concordance with their research, with the PVL technique requiring a significantly lower (P < 0.001) volume of air for ETT cuff inflation when compared to the auscultation method (MOV). Over-inflation of the ETT cuff causes high cuff pressures, reducing tracheal mucosa perfusion, while low pressure may lead to pulmonary aspiration of oropharyngeal contents.[10,12,13] The maximum mean cuff pressure was in the manual palpation group, nearly identical in the MOV and precise pressure groups, while the lowest cuff pressure occurred in the PVL technique. These findings align with previous studies by Kaki et al.[12] The manual palpation method, used conventionally, has been proven to be unreliable and leads to overinflation.[14] The present study also found the MP technique to have the highest cuff pressure after inflation, similar to a study conducted by Tsaousi et al.[14]
The relevance of cuff pressure variations lies not only in the numerical differences but also in how they translate into post-operative airway outcomes. Using a scoring system similar to Zhou Y,[9] postoperative cough, sore throat, and hoarseness of voice were observed in the present study. The PVL technique had lower mean complication scores than all other groups at 30 minutes for sore throat, hoarseness of voice, and cough. At the 24-hour mark, the IPP group showed a lower mean sore throat score (P < 0.001), while the PVL technique was associated with a lower mean hoarseness of voice score (P < 0.001). Similar to the findings by Almarakbi and Tsaousi, we observed statistically significant complication scores at both time intervals in the manual palpation group, except for postoperative cough, which was insignificant at the 24-hour interval.[7,14] This has been attributed to the higher cuff inflation pressure. Zhu et al. found that the occurrence of sore throat was comparable between the cuff pressure gauge approach and the automated cuff controller method, while the automated cuff controller method can potentially decrease the severity of sore throat and hoarseness.[15] The existing literature supports the findings of our study; the manual palpation technique is implicated in the occurrence of higher incidence and severity of post-operative complications, while the PVL technique was found to be a safer method.
This study has certain limitations. To maintain comparability across groups, only healthy patients without lung disease were included; different results may be seen in patients with altered respiratory mechanics. The duration of surgery and intubation was not analysed, which may influence postoperative airway morbidity. Finally, the study population was drawn from a single geographical region in North India, which may affect the generalisability of the results.
CONCLUSION
Our findings indicate that the pressure–volume loop technique offers a safer and more consistent approach to endotracheal tube cuff management than conventional methods, with lower inflation volumes, reduced cuff pressures, and fewer postoperative complications. Broader evaluation of other techniques may further inform best practices and contribute to the development of standardised guidelines.
Study data availability
De-identified data may be requested with reasonable justification from the authors (email to the corresponding author) and shall be shared after approval as per the authors’ institution’s policy.
Disclosure of use of artificial intelligence (AI)-assistive or generative tools
The AI tools or language models (LLMs) have not been utilised in the manuscript, except that software has been used for grammar corrections.
Declaration of use of permitted tools
The scores [cough, hoarseness of voice, sore throat] are freely available and not copyrighted.
Authors contributions
SM was involved in literature search, conduct of cases, data acquisition, data analyses, manuscript preparation, JS was involved in Concepts, Design, Definition of intellectual content, literature search, manuscript editing, MG was involved in Definition of intellectual content, literature search, manuscript editing, RS was involved in Conduct of cases, data acquisition, manuscript preparation, AG was involved in Concepts, Design, Definition of intellectual content, DKS was involved in Concepts, Design, Definition of intellectual content.
Conflicts of interest
Dr. Anju Grewal, who is one of the co-authors of this manuscript, is an Editorial Board member of this journal. She was not involved in any decision-making process, and an independent editor handled this manuscript. There are no other conflicts of interest.
Funding Statement
Nil.
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