RecruitingNot ApplicableNCT06218836

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

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


Sponsor

Sir Ganga Ram Hospital

Enrollment

250 participants

Start Date

Jan 23, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria12

  • 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

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Interventions

OTHERPre-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.

OTHERNon-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.


Locations(1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

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NCT06218836


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