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

NCT ID: NCT06218836

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2025-10-30

Brief 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.

Detailed Description

Postoperative sore throat (POST) has long been a common and nagging complication following conventional direct laryngoscopy-intubation (DLI) procedure. A significant quantum of POST incidence during DLI in non-difficult airway (NDA) could be attributed to inter-operator variability in approach, experience, proficiency, and equipment (e.g., type of laryngoscope/tracheal tube). Additional factors determining the occurrence of POST, include size of the tracheal tube, cuff pressure, rough tube pass, and reattempts, among others. Several pharmacologic (applying lidocaine gel, inhaled corticosteroids and EMLA cream on tracheal tube cuff surface) and non- pharmacologic measures/modalities (e.g., tracheal tube cuff pressure control, optimization of tracheal tube size, applying gel) have been employed to preclude/diminish POST, however, neither the incidence nor the suffering of patients have come down yet following these interventions. Friction injury to the tracheal mucosa during the passage of ETT is one of the important contributing factors to POST but has not been adequately evaluated. Friction injury to the upper airway mucosa not only occurs during rough or repeated passage of ETT through the glottic-inlet but also when the ETT cuff comes in contact with the tracheal mucosa during dynamic passage of ETT through the glottis.

Traditional approach to reduce reduce postoperative sore throat is by containing the intracuff pressure with use of non-inflated tube, and consequently, reducing static pressure burden on tracheal mucosa. No study has explored the impact of modulation of obligate kinetic contact-friction that occurs during passage of tube across the glottic-inlet. A preemptive limited inflation of tracheal tube cuff before actual intubation may modulate the kinetic-contact friction during the passage of the tracheal tube cuff past the vocal cords, and hence may help reduce postoperative sore throat in these patients. We plan this randomized trial to compare the effect/efficacy of intubation with pre-inflated tracheal tube on the incidence of postoperative sore throat in patients with anticipated non-difficult airway.

Conditions

Postoperative Sore Throat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Intubation with pre-inflated ETT

Patient's trachea will be intubated using pre- inflated endotracheal tube (ETT)

Group Type: ACTIVE_COMPARATOR

Pre-inflated endotracheal tube

Intervention Type: OTHER

The ETT (males: size 7.5 mm ID, females: size 6.5 mmID) will be taken out from the wrapper and submerged in 0.9% normal saline till the proximal margin of the cuff. Then, the cuff will be inflated to 40 cm of H2O to gain full stretch inflation.Thereafter the cuff will be deflated with the help of cuff inflator-deflator device to maintain intracuff pressure of 4 cm H2O The external cuff balloon will be obliterated with a soft clamp to ensure that at the time of passage of tube through the glottic-inlet, the tube cuff does not get deflated due to pressure equalization with the external balloon.

Intubation with non-inflated ETT

Patient's trachea will be intubated using non-inflated ETT

Group Type: ACTIVE_COMPARATOR

Non-inflated endotracheal tube

Intervention Type: OTHER

The ETT (males: size 7.5 mm ID, females: size 6.5 mmID) will be taken out from the wrapper and submerged in 0.9% normal saline till the proximal margin of the cuff. Thereafter the endotracheal intubation will be done.

Interventions

Pre-inflated endotracheal tube

The ETT (males: size 7.5 mm ID, females: size 6.5 mmID) will be taken out from the wrapper and submerged in 0.9% normal saline till the proximal margin of the cuff. Then, the cuff will be inflated to 40 cm of H2O to gain full stretch inflation.Thereafter the cuff will be deflated with the help of cuff inflator-deflator device to maintain intracuff pressure of 4 cm H2O The external cuff balloon will be obliterated with a soft clamp to ensure that at the time of passage of tube through the glottic-inlet, the tube cuff does not get deflated due to pressure equalization with the external balloon.

Intervention Type: OTHER

Non-inflated endotracheal tube

The ETT (males: size 7.5 mm ID, females: size 6.5 mmID) will be taken out from the wrapper and submerged in 0.9% normal saline till the proximal margin of the cuff. Thereafter the endotracheal intubation will be done.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Ganga Ram Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nitin Sethi, DNB

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amitabh Dutta, MD, PGDHR

Role: STUDY_DIRECTOR

Sir Ganga Ram Hospital

Locations

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Nitin Sethi, DNB

Role: CONTACT

nitinsethi77@yahoo.co.in

00919717494498

Amitabh Dutta, MD,PGDHR

Role: CONTACT

duttaamitabh@yahoo.co.in

00919810848064

Facility Contacts

Nitin Sethi, DNB

Role: primary

nitinsethi77@yahoo.co.in

00919717494498

Amitabh Dutta, MD, PGDHR

Role: backup

duttaamitabh@yahoo.co.in

00919810848064

Other Identifiers

EC/12/23/2408

Identifier Type: -

Identifier Source: org_study_id