Postoperative Sore Throat Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | January 30, 2025 |
Est. primary completion date | January 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | Sir Ganga Ram Hospital | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Sir Ganga Ram Hospital |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of postoperative sore throat | Sore throat will be assessed using a 4-point scale: '0' no sore throat to '3' severe sore throat.Any score >= 1 will be counted as a sore throat incidence | From time of extubation of trachea till 24-hours postoperatively | |
Secondary | Severity of postoperative sore throat | Sore throat will be assessed using a 4-point scale: '0' no sore throat, '1' Mild sore throat (complained of sore throat only on enquiry), '2' Moderate sore throat (complained of sore throat on his/her own), and '3' Severe sore throat (change of voice or hoarseness). Number of patients with no sore throat, mild sore throat, moderate sore throat, and severe sore throat will be noted | From time of extubation of trachea till 24-hours postoperatively | |
Secondary | Incidence and severity of postoperative cough | Postoperative cough will be assessed using a 4-point scale: 0- no cough, 1- mild cough (cough which is less than a common cold), 2-moderate cough (cough which is similar to a common cold), and 3- severe cough (cough which is more than a common cold). | From time of extubation of trachea till 24-hours postoperatively | |
Secondary | Incidence and severity of postoperative hoarseness of voice | Postoperative hoarseness of voice will be assessed using a 4-point scale: 0- no hoarseness (no change in speech appreciated even on enquiry), 1- mild hoarseness (minimal change in speech quality. Answered by patient on enquiry), 2-moderate hoarseness (moderate change in speech quality which is self-complained by the patient), and 3- severe hoarseness (recognizable change in speech quality). | From time of extubation of trachea till 24-hours postoperatively |
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