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NCT06218836
Effect of Inflated Versus Non-inflated Endotracheal Tube on Sore Throat
NA trial testing Pre-inflated endotracheal tube in Postoperative Sore Throat in 250 participants. Currently enrolling.
30 September 2025
Quick facts
| Lead sponsor | Sir Ganga Ram Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 250 |
| Start date | 23 January 2024 |
| Primary completion | 30 September 2025 |
| Estimated completion | 30 October 2025 |
| Sites | 1 location across India |
Drugs / interventions tested
- Pre-inflated endotracheal tube
- Non-inflated endotracheal tube
Conditions studied
- Postoperative Sore Throat — all drugs for Postoperative Sore Throat →
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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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06218836 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sir Ganga Ram Hospital
- Last refreshed: 25 March 2025
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