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Effect of Inflated Versus Non-inflated Endotracheal Tube on Sore Throat

NCT06218836 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-04-27

No results posted yet for this study

Summary

Postoperative sore throat (POST) is a common morbidity following upper airway access-control with direct laryngoscopy-intubation (DLI) technique. Various reasons (size of the tracheal tube, cuff pressure, rough tube pass, and reattempts, among others) have been cited and management strategies (pharmacologic: applying lidocaine gel/EMLA cream on the cuff surface; non-pharmacologic measures: tracheal tube cuff pressure control, optimization of tracheal tube size, applying lubricating gel) have been tried, but none has been able to decrease the incidence of POST nor has been able to decrease the suffering of patients.

Traditionally, intubation is performed with a deflated endotracheal tube and the cuff is later inflated to secure the tube in desired position. The striated folds present in the deflated cuff incurs additional dynamic friction that traumatizes upper airway mucosa during the procedure, causing the risk of POST. While accentuated friction burden on the posterior part of vocal cords and the tracheal mucosa has been studied recently, there has been no work on understanding the kinetic contact- friction ensued by a passing tracheal tube/cuff. We speculate that dynamic contact-friction generated at the time of passing of a cuffed tracheal tube is the major active component which has potential to cause actual tissue trauma and inflammation resulting in adverse effects (POST, hoarseness, throat pain, cough). This study aims to evaluate the effects of reducing dynamic/kinetic contact-friction by employing a pre-inflated tracheal tube cuff to pass the vocal cords at the time of orotracheal intubation.

Conditions

  • Postoperative Sore Throat

Interventions

OTHER

Pre-inflated endotracheal tube

The ETT (males: size 7.5 mm ID, females: size 6.5 mmID) will be taken out from the wrapper and submerged in 0.9% normal saline till the proximal margin of the cuff. Then, the cuff will be inflated to 40 cm of H2O to gain full stretch inflation.Thereafter the cuff will be deflated with the help of cuff inflator-deflator device to maintain intracuff pressure of 4 cm H2O The external cuff balloon will be obliterated with a soft clamp to ensure that at the time of passage of tube through the glottic-inlet, the tube cuff does not get deflated due to pressure equalization with the external balloon.

OTHER

Non-inflated endotracheal tube

The ETT (males: size 7.5 mm ID, females: size 6.5 mmID) will be taken out from the wrapper and submerged in 0.9% normal saline till the proximal margin of the cuff. Thereafter the endotracheal intubation will be done.

Sponsors & Collaborators

  • Sir Ganga Ram Hospital

    lead OTHER

Principal Investigators

  • Amitabh Dutta, MD, PGDHR · Sir Ganga Ram Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2025-07-21
Completion
2025-07-21

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218836 on ClinicalTrials.gov