NCT06349005

Brief Summary

In this prospective, randomized, controlled trial, the purpose is to compare Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope in terms of hemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

January 12, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

February 26, 2024

Last Update Submit

May 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Hemodynamic response

    Change from baseline invasive blood pressure

    Change from baseline Systolic or Diastolic or mean Blood Pressure at 10 minutes

  • Hemodynamic response

    Change from baseline heart rate

    Change from baseline heart rate at 10 minutes

Secondary Outcomes (2)

  • Intubation time

    180 seconds

  • Visualization of the glottis

    180 seconds

Study Arms (4)

Group Storz VL

ACTIVE COMPARATOR

Patients will undergo intubation with the Storz Videolaryngoscope®, during which their hemodynamic responses will be documented.

Other: Tracheal intubation using Storz VL

Group MacGrath VL

ACTIVE COMPARATOR

Patients will undergo intubation with the McGrath Videolaryngoscope®, during which their hemodynamic responses will be documented.

Other: Tracheal intubation using MacGrath VL

Group EzVision VL

ACTIVE COMPARATOR

Patients will undergo intubation with the EzVision Videolaryngoscope®, during which their hemodynamic responses will be documented.

Other: Tracheal intubation using EzVision VL

Group Traditional

ACTIVE COMPARATOR

Patients will undergo intubation with the traditional (Macintosh) laryngoscopy, during which their hemodynamic responses will be documented.

Other: Tracheal intubation using Macintosh laryngoscopy

Interventions

Video-assisted intubation technique using Storz VL

Group Storz VL

Traditional intubation technique using Macintosh laryngoscopy

Group Traditional

Video-assisted intubation technique using MacGrath VL

Group MacGrath VL

Video-assisted intubation technique using EzVision VL

Group EzVision VL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range between 18 and 75 years.
  • Scheduled for elective coronary artery bypass surgery.
  • Classified under American Society of Anesthesiologists (ASA) physical status II-III.
  • Patients with no history of difficult intubation or associated risk factors.

You may not qualify if:

  • Emergency case
  • Predicted difficult airways
  • Body mass index \> 35 kilograms per meter squared
  • Baseline hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr

Study Record Dates

First Submitted

February 26, 2024

First Posted

April 5, 2024

Study Start

January 12, 2025

Primary Completion

May 28, 2025

Study Completion

May 28, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations