Comparative study of airway access in cervical spine injury by two different methods

Completed

• Conditions: All patients between 18 and 65 years, belonging to ASA status I – III with upper cervical spine (C1 to C4) pathology and resultant instability, scheduled for elective surgery under GA

• Registration Number: CTRI/2017/10/010231

Brief Summary

This study aims to compare awake orotracheal intubation using two different techniques- Mc Grath videolaryngoscopy assisted and fibreoptic guided in patients with risk of secondary cervical cord injury due to unstable cervical spine coming for definitive surgery at NIMHANS, Bangalore, India during June 2016 to November 2017.

The primary objective is to assess cervical-spine movement at C1/2 and C2/3 level during intubation. Secondary objectives are to assess change in the neurological status (motor power and sensory examination in both upper and lower limbs) during intubation process and evaluate hemodynamic changes, intubation success and patient satisfaction regarding awake intubation with these two techniques.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-15
• Study Completion: 2017-10-31
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

All patients aged between 18 and 65 years, belonging to ASA status I – III physical status with upper cervical spine (C1 to C4) pathology and resultant instability, scheduled for elective stabilization surgery, under general anaesthesia at National Institute of Mental Health and Neurosciences, Bengaluru.

Exclusion Criteria

Morbidly obese patients Difficult airway- oropharyngeal pathology or mouth opening less than 3 cm Patients who refuse to give consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to assess cervical-spine movement at C1/2 and C2/3 level during intubation.	T1- Timepoint 1 is baseline X ray with cervical spine in neutral position | T2- timepoint 2 is x ray taken during best laryngoscopy view using VL(McGrath) or with fibreoptic scope in trachea with Fibreoptic bronchoscope | T3- is Timepoint 3 when the tube is in trachea in both the groups

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are to assess change in the neurological status (motor power and sensory examination in both upper and lower limbs) during intubation process and evaluate hemodynamic changes, intubation success and patient satisfaction regarding awake intubation with these two techniques.

Trial Locations

Locations (1)

NIMHANS; 🇮🇳 Bangalore, KARNATAKA, India

NIMHANS

🇮🇳Bangalore, KARNATAKA, India

Dr Kaustuv Dutta

Principal investigator

9535050421

kaustuv.dutta@gmail.com