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

Sponsor
King Edward Memorial Hospital, Mumbai (Other)
Overall Status
Completed
CT.gov ID
NCT05561231
Collaborator
(none)
68
1
2
12
5.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intubation with C blade
  • Procedure: Intubation with D blade
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective single blinded randomised controlled trialProspective single blinded randomised controlled trial
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Nov 1, 2018
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Time taken for successful intubation [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

Secondary Outcome Measures

  1. Time taken to obtain the best Cormack-Lehane grade [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

  2. Number of attempts, external manouvres, complications [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seth GSMC and KEM Hospital Mumbai Maharashtra India 400012

Sponsors and Collaborators

  • King Edward Memorial Hospital, Mumbai

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sandhya Narayanan P, Principle investigator, King Edward Memorial Hospital, Mumbai
ClinicalTrials.gov Identifier:
NCT05561231
Other Study ID Numbers:
  • EC/182/2018
First Posted:
Sep 30, 2022
Last Update Posted:
Sep 30, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sandhya Narayanan P, Principle investigator, King Edward Memorial Hospital, Mumbai
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2022