To assess the time taken for successful intubation using bougie vs endotracheal tube and stylet in patients with cervical immobilization undergoing cervical spine surgery.

PGIMER1 site in 1 country86 target enrollmentStarted: July 22, 2020Last updated: June 30, 2020

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Not yet recruiting
Sponsor: PGIMER
Enrollment: 86
Locations: 1
Primary Endpoint: Time to successful intubation facilitated by the bougie vs the ET with stylet using video-laryngoscope

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

There are studies which have compared the intubation success between bougie and stylet in varied group of patients including difficult airways both actual and simulated, but there is paucity of literature comparing ETI using bougie and ETI with stylet in cervical immobilized patients. We hypothesized that time to successful intubation would be less with Bougie than ET with stylet.

Study Design

Study Type: Interventional
Allocation: Random Number Table
Masking: Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages: 18.00 Year(s) to 65.00 Year(s) (—)
Sex: All

Inclusion Criteria

•1.Age group: 18 yrs and Above 2.ASA Status: ASA I and II 3.Patients with cervical spine immobilization with a collar or with traction 4.Undergoing cervical spine surgery 5.Using a Video laryngoscope to visualize the cords.

Exclusion Criteria

•1.ASA III or IV Patients 2.AGE <18 YRS 3.Mouth opening of less than three fingers 4.Pregnant women 5.Patients with known distortion of the upper airway or glottic structures (eg: angioedema, epiglottitis, laryngeal mass or malignancy).

Outcomes

Primary Outcomes

Time to successful intubation facilitated by the bougie vs the ET with stylet using video-laryngoscope

Time Frame: Baseline, at neutral position. | point of insertion of the ETI through the glottis aperture.

Secondary Outcomes

First attempt successful intubation, overall success rate of ETI, Cervical spine motion using fluoroscopy, CL grade and rate of complications in the form of desaturation, bleeding, broken teeth, trachea-bronchial perforation, pneumothorax, vocal cord injury would be assessed as secondary outcomes(Baseline, at neutral position.)

Investigators

Sponsor

PGIMER

Sponsor Class

Research institution and hospital

Study Sites (1)

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