Effect of Inflated Versus Non-inflated Endotracheal Tube on Sore Throat (NCT06218836) | Clinical Trial Compass
CompletedNot Applicable
Effect of Inflated Versus Non-inflated Endotracheal Tube on Sore Throat
India250 participantsStarted 2024-01-23
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ASA physical status I and II
* Patients with anticipated non-difficult airway with the following characteristics:
i. Normal head and neck movements ii. Adequate mouth opening iii. No retrognathia or prognathia iv. Normal dentition
* Surgeries with anticipated duration of 40 minutes - 3 hours
Exclusion Criteria:
* Obese patients (BMI \> 33 kg/m2)
* Requiring use of intubation aids such as bougie, stylet or video-laryngoscope
* Recent history of steroid or non-steroidal anti-inflammatory drug use
* Systemic illness with presenting complaints of sore/dry throat (diabetics with polydipsia, hypertensives on diuretics, moribund bed ridden patients)
* History of airway related morbidity post operative sore throat \[POST\]
* Patients with a history of chronic smoking (1 pack per day for 10 years) chewing tobacco, and tobacco-related products
* Patients undergoing head and neck, intraoral/nasal surgery, or recent history of such surgery
* Patients with a past surgical history of tracheostomy (post decannulation)
* Surgery in prone position
* Ongoing upper and lower respiratory tract inflammation/infection
* Patients with anticipated postoperative mechanical ventilation
* Refusal to participate in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of postoperative sore throat
Timeframe: From time of extubation of trachea till 24-hours postoperatively