Comparing Ease of Endotracheal Intubation Using C Blade and D Blade of CMAC Videolaryngoscope in Patients Undergoing Elective Cervical Spine Surgery

September 29, 2022 updated by: Sandhya Narayanan P, King Edward Memorial Hospital, Mumbai

A Prospective Single Blinded Randomised Controlled Trial to Compare Endotracheal Intubation Using C Blade and D Blade of CMAC Videolaryngoscope in Patients Undergoing Elective Cervical Spine Surgery

This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Manual in-line stabilisation is used to immobilise the neck during endotracheal intubation in patients undergoing cervical spine surgery to prevent secondary spinal cord damage. This makes visualisation of the glottis difficult with conventional laryngoscopy which can be overcome with videolaryngoscope. CMAC Videolaryngoscope has the conventional blade (C blade) and the highly angulated D blade which was introduced to aid in difficult airway. This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.

Methodology: After Institutional Ethics Committee approval and obtaining informed consent, 68 patients undergoing elective cervical spine surgery were randomised into 2 groups - C (intubated with C blade) or D (intubated with D blade) (n=34 each) by computer generated randomisation. After induction of general anaesthesia, manual in-line stabilisation of the cervical spine was achieved and intubation was attempted by experienced anaesthesiologist with the C blade or D blade according to the group. The time taken for successful intubation, time taken for optimum glottic visualisation, the number of attempts, additional manouvres required for successful intubation and the incidence of complications were compared.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Seth GSMC and KEM Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with ASA (American Society of Anaesthesiology) grade one and two,
  • aged 18 years and older,
  • Patients with mouth opening more than two and a half fingers (inter-incisor distance >3cm)

Exclusion Criteria:

  • Patients who were unwilling to be a part of the study,
  • patients with any oral pathology, hiatus hernia, pregnant women,
  • patients with severe systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group C
Group of patients intubated with C blade of CMAC videolaryngoscopes
Procedure: Intubation with C blade
Intubation with C blade of CMAC videolaryngoscope
Active Comparator: Group D
Group of patients intubated with D blade of CMAC videolaryngoscope
Procedure: Intubation with D blade
Intubation with D blade of CMAC videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time taken for successful intubation
Time Frame: During procedure
Comparing the time taken for successful intubation using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine
During procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time taken to obtain the best Cormack-Lehane grade
Time Frame: During procedure
Comparing the time taken to obtain the best Cormack-Lehane grade using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine
During procedure
Number of attempts, external manouvres, complications
Time Frame: During procedure
Comparing the number of attempts for successful endotracheal intubation, external manoeuvres or adjuncts required, complications caused using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Memorial Hospital, Mumbai

Investigators

  • Principal Investigator: Sandhya N Narayanan P, MD, Seth GSMC and KEMH Mumbai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/182/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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