A clinical trial to compare three different intubating modalities in patients,while creating a difficult airway scenario by immobilizing the cervical spine

Phase 2

Completed

Conditions: Medical and Surgical,

Registration Number: CTRI/2021/08/035683

Lead Sponsor: Hamdard Institute of Medical Sciences and Research

Brief Summary: This study is a three parallel arm randomised controlled trial, to determine weather Blockbuster intubating Laryngeal mask airway and King Vision videolaryngoscope can be used as an alternative to gold standard Flexible Fibreoptic Scope in patients with cervical immobilisation. The objectives of the study are-

1. To compare total time of intubation

2. To compare 1st attempt success rate between the groups

3. To compare intubation attempts between the groups

4. To compare hemodynamic response

5. To compare intraoperative complication like trauma to lips, teeth, mucosa and other soft tissues and post operative complications like sore throat and cough.

The trial is conducted in a single centre in The operation theatres of Hamdard Institute of Medical Sciences and Research.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

Patients with American Society of Anaesthesiology (ASA) physical status I and II, of either sex, scheduled for elective surgery under general anaesthesia requiring endotracheal intubation.

Exclusion Criteria

Patients refusal to give consent 2.
Patients with laryngeal and pharyngeal pathology and restricted neck movements 3.
Known or anticipated difficult airway ( Mallampati score 3and 4, interincisor distance < 2.5 cms, thyromental distance <6cms, sternomental distance <12cms) 4.
Edentulous patients 5.
Pregnant patients 6.
Patients with BMI >35kg/m2 7.
Patietns with clinical or radiological evidence of unstable cervical spine abnormalities.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare total time of intubation (TTI) using Blockbuster ILMA, King Vision Videolaryngoscope and Flexible Fibreoptic scope with simulated immobilized cervical spine in ASA I and II patients undergoing General Anaesthesia .	To compare total time of intubation (TTI) at baseline.

Secondary Outcome Measures

Name	Time	Method
1. To compare first attempt success rate between the groups.	2. To compare intubation attempts between the groups

Trial Locations

Locations (1): operation rooms, Hamdard Institute of Medical Sciences and Research and HAHC Hospital
🇮🇳
South, DELHI, India
operation rooms, Hamdard Institute of Medical Sciences and Research and HAHC Hospital
🇮🇳South, DELHI, India
Neha Sinha
Principal investigator
9990122034
nehasinha9196@gmail.com