NCT05561231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 27, 2022

Last Update Submit

September 29, 2022

Conditions

Keywords

Manual in-line stabilisationC bladeD blade

Outcome Measures

Primary Outcomes (1)

  • Time taken for successful intubation

    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 Outcomes (2)

  • Time taken to obtain the best Cormack-Lehane grade

    During procedure

  • Number of attempts, external manouvres, complications

    During procedure

Study Arms (2)

Group C

ACTIVE COMPARATOR

Group of patients intubated with C blade of CMAC videolaryngoscopes

Procedure: Intubation with C blade

Group D

ACTIVE COMPARATOR

Group of patients intubated with D blade of CMAC videolaryngoscope

Procedure: Intubation with D blade

Interventions

Intubation with C blade of CMAC videolaryngoscope

Group C

Intubation with D blade of CMAC videolaryngoscope

Group D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seth GSMC and KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (2)

  • Hazarika H, Saxena A, Meshram P, Kumar Bhargava A. A randomized controlled trial comparing C Mac D Blade and Macintosh laryngoscope for nasotracheal intubation in patients undergoing surgeries for head and neck cancer. Saudi J Anaesth. 2018 Jan-Mar;12(1):35-41. doi: 10.4103/sja.SJA_239_17.

    PMID: 29416454BACKGROUND
  • Sinha R, Ray BR, Sharma A, Pandey RK, Punj J, Darlong V, Trikha A. Comparison of the C-MAC video laryngoscope size 2 Macintosh blade with size 2 C-MAC D-Blade for laryngoscopy and endotracheal intubation in children with simulated cervical spine injury: A prospective randomized crossover study. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):509-514. doi: 10.4103/joacp.JOACP_106_18.

    PMID: 31920236BACKGROUND

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Sandhya N Narayanan P, MD

    Seth GSMC and KEMH Mumbai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective single blinded randomised controlled trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations