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

NCT06218836 | Completed

• 1 other identifier: EC/12/23/2408
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Sore Throat

Keywords

endotracheal tube; inflated; sore throat; friction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Severity of postoperative sore throat

  From time of extubation of trachea till 24-hours postoperatively

• Incidence and severity of postoperative cough

  From time of extubation of trachea till 24-hours postoperatively

• Incidence and severity of postoperative hoarseness of voice

  From time of extubation of trachea till 24-hours postoperatively

Study Arms (2)

Intubation with pre-inflated ETT

ACTIVE COMPARATOR

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

Other: Pre-inflated endotracheal tube

Intubation with non-inflated ETT

ACTIVE COMPARATOR

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

Other: Non-inflated endotracheal tube

Interventions

Non-inflated endotracheal tube 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.

Intubation with non-inflated ETT

Pre-inflated endotracheal tube 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 pre-inflated ETT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Amitabh Dutta, MD, PGDHR

  Sir Ganga Ram Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: An independent investigator, not involved in the assessment of patient, will assign the allocated intervention. The patient and the postoperative outcome assessor will be blinded to the intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: Patients will be randomly divided into two groups: Group I: Intubation with pre-inflated endotracheal tube Group II: Intubation with non-inflated endotracheal tube

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: January 23, 2024
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)