Comparing inflated and non-inflated endotracheal tubes for sore throat relief
Effect of Kinetic Contact-friction Modulation With a Pre-inflated Tracheal Tube Cuff on Postoperative Sore Throat in Adults With Anticipated Non-difficult Airway: a Randomized Controlled Study
NA · Sir Ganga Ram Hospital · NCT06218836
This study is testing whether using inflated endotracheal tubes instead of non-inflated ones can help reduce sore throats after surgery for patients who need to be intubated.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sir Ganga Ram Hospital (other) |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT06218836 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effect of using inflated versus non-inflated endotracheal tubes on the incidence of postoperative sore throat (POST) following direct laryngoscopy-intubation. The study aims to determine whether pre-inflating the cuff of the endotracheal tube can reduce friction injury to the upper airway mucosa, which is a contributing factor to POST. Patients undergoing surgeries with anticipated durations of 40 minutes to 3 hours and classified as ASA physical status I and II will be included. The trial will compare outcomes between the two groups to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are patients classified as ASA physical status I and II with anticipated non-difficult airways and undergoing surgeries lasting between 40 minutes and 3 hours.
Not a fit: Patients with obesity, recent steroid use, systemic illnesses causing throat discomfort, or those undergoing head and neck surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postoperative sore throat, improving patient comfort and recovery.
How similar studies have performed: While various interventions have been attempted to reduce POST, this specific approach comparing inflated and non-inflated tubes has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Delhi, Delhi
- Sir Ganga Ram Hospital — New Delhi, Delhi, India (RECRUITING)
Study contacts
- Study coordinator: Nitin Sethi, DNB
- Email: nitinsethi77@yahoo.co.in
- Phone: 00919717494498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Sore Throat, endotracheal tube, inflated, sore throat, friction