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Clinical Trials/CTRI/2018/05/013598
CTRI/2018/05/013598RecruitingUnknown

Comparative evaluation of a videolaryngoscope with a direct laryngoscope for tracheal intubation with manual in line stabilization of neck in patients undergoing cervical spine surgery

Vardhman Mahavir Medical College and Safdarjung Hospital1 site in 1 country60 target enrollmentStarted: June 11, 2017Last updated:

Trial Snapshot

Phase
Unknown
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To compare Intubation difficulty scale score with C-MAC D-blade videolaryngoscope and McCoy laryngoscope for tracheal intubation with manual in line stabilization of neck in the study population

Study Overview

Brief Summary

PRIMARY OBJECTIVE

To compare intubation difficulty scale score with C-MAC D-blade videolaryngoscope and McCoy laryngoscope for tracheal intubation with manual in line stabilization of neck  in the study population.

SECONDARY OBJECTIVES

To compare total time taken to secure the airway, number of intubation attempts, ease of insertion of the laryngoscope and percentage of glottic opening score  with C-MAC D-blade videolaryngoscope  and McCoy laryngoscope in the study population.

HYPOTHESIS

C-MAC D-blade videolaryngoscope will provide better glottic visualization and decrease intubation difficulty as compared to McCoy laryngoscope in patients with cervical spine immobilization.

Study Design

Study Type
Interventional
Allocation
Permuted block randomization, fixed
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • study will be conducted on a) 60 adult patients of 18-60 years of age , b) either sex and c) American society of Anaesthesiologists (ASA) physical status I , II and III d)scheduled to undergo elective cervical spine surgery requiring tracheal intubation with manual in line stabilization of neck under general anaesthesia.

Exclusion Criteria

  • a) Patients with following predictors of difficult airway : 1)Modified Mallampati class IV, 2)Interincisor distance < 4.0 cm, 3)Upper lip bite test class >1, 4)Buck teeth and poor dentition with high risk of damage, 5)Oropharyngeal pathology or facial abnormality, 6)BMI >30kg /metre
  • b) Haemodynamic or pulmonary compromise, high risk of pulmonary aspiration and cardiac disease and Hypertension.
  • c) Pregnancy.

Outcomes

Primary Outcomes

To compare Intubation difficulty scale score with C-MAC D-blade videolaryngoscope and McCoy laryngoscope for tracheal intubation with manual in line stabilization of neck in the study population

Time Frame: At the time of intubation

Secondary Outcomes

  • Total time taken to secure the airway,(Number of intubation attempts ,)

Investigators

Sponsor
Vardhman Mahavir Medical College and Safdarjung Hospital
Sponsor Class
Government medical college

Study Sites (1)

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