NCT04433884

Brief Summary

This study is being done to compare hemodynamic response upon endotracheal intubation using either conventional laryngoscopy with Macintosh blade versus C-Mac video laryngoscope in patients undergoing elective coronary artery bypass grafting without anticipated difficult airway.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 7, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

June 11, 2020

Last Update Submit

June 15, 2020

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (2)

  • Changes in blood pressure (in millimeters of Hg)

    Hemodynamic response

    Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation

  • Changes in heart rate (beats per minute)

    Hemodynamic response

    Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation

Secondary Outcomes (2)

  • Arrhythmias

    Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation

  • Perioperative myocardial ischemia

    Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation

Study Arms (2)

Conventional MAC Laryngoscope

EXPERIMENTAL

Patients in this group will undergo intubation using conventional macintosh laryngoscope

Device: Endotracheal intubation using a laryngoscope

C-MAC Video laryngoscope

EXPERIMENTAL

Patients in this group will undergo intubation using video C-Mac laryngoscope

Device: Endotracheal intubation using a laryngoscope

Interventions

Endotracheal intubation using a laryngoscopeDEVICE

Patients will undergo intubation using 2 different types of laryngoscopes and their hemodynamic response would be recorded

C-MAC Video laryngoscopeConventional MAC Laryngoscope

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 35-65
  • Elective Coronary Artery By Pass Grafting
  • American Society Of Anesthesiologist III/IV
  • Unanticipated difficult airway
  • Mallampati I-II

You may not qualify if:

  • Obese Body Mass Index \> 35kg/m2
  • Left Main Coronary Artery critical Disease
  • Recent MI or unstable Angina
  • Left heart failure/ Left ventricular ejection fraction\<35%
  • Upper lip bite test class III
  • Thyromental distance \<6.0 cm
  • Emergency surgery
  • Anticipated difficult airway
  • Respiratory Diseases
  • Bleeding diathesis
  • Neurological deficit
  • Limited nuchal Range of motion
  • Gastro Esophageal Reflux Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology

Karachi, Sindh, Pakistan

RECRUITING

Central Study Contacts

Sehrish Khan, MBBS

CONTACT

923347126366sehrish.khan@aku.edu

Khalid Samad, MBBS,FCPS(Anesthesiology)

CONTACT

923343311603khalid.samad@aku.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Computer generated randomization using envelopes
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

June 7, 2020

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations

PA(1)