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NCT06218836

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

Recruiting now NA Last updated 25 March 2025
What this trial tests

NA trial testing Pre-inflated endotracheal tube in Postoperative Sore Throat in 250 participants. Currently enrolling.

Timeline
23 January 2024
Primary endpoint
30 September 2025
30 October 2025

Quick facts

Lead sponsorSir Ganga Ram Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment250
Start date23 January 2024
Primary completion30 September 2025
Estimated completion30 October 2025
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Sir Ganga Ram Hospital

Who can join

Adults 18 to 65, any sex, with Postoperative Sore Throat. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Sir Ganga Ram Hospital trials

Trials by the same sponsor.

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