Laryngoscopy and Coronary Artery Bypass Graft Surgery (VL)

Hemodynamic Response to Various Laryngoscopes During Tracheal Intubation in CABG Patients

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).

Study Overview

• Status: Completed
• Conditions: Videolaryngoscopy
• Intervention / Treatment: Other: Tracheal intubation using Storz VL; Other: Tracheal intubation using MacGrath VL; Other: Tracheal intubation using EzVision VL; Other: Tracheal intubation using Macintosh laryngoscopy

Detailed Description

During endotracheal intubation, laryngoscopy can significantly affect hemodynamic responses, including tachycardia and elevated blood pressure, which may be particularly detrimental to individuals with cardiovascular conditions. Various studies have explored the hemodynamic reactions associated with laryngeal stimulation through different intubation devices. Researchers hypothesize that endotracheal intubation using video laryngoscopy will elicit a reduced hemodynamic response compared to traditional (Macintosh) laryngoscopy. In this prospective and randomized clinical study, the purpose is to compare the Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope concerning haemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Konya City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Storz VL; Patients will undergo intubation with the Storz Videolaryngoscope®, during which their hemodynamic responses will be documented.	Other: Tracheal intubation using Storz VL; Video-assisted intubation technique using Storz VL
Active Comparator: Group MacGrath VL; Patients will undergo intubation with the McGrath Videolaryngoscope®, during which their hemodynamic responses will be documented.	Other: Tracheal intubation using MacGrath VL; Video-assisted intubation technique using MacGrath VL
Active Comparator: Group EzVision VL; Patients will undergo intubation with the EzVision Videolaryngoscope®, during which their hemodynamic responses will be documented.	Other: Tracheal intubation using EzVision VL; Video-assisted intubation technique using EzVision VL
Active Comparator: Group Traditional; Patients will undergo intubation with the traditional (Macintosh) laryngoscopy, during which their hemodynamic responses will be documented.	Other: Tracheal intubation using Macintosh laryngoscopy; Traditional intubation technique using Macintosh laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	The duration from when the laryngoscope passes through the teeth until it is withdrawn back to the teeth will be measured.	180 seconds
Visualization of the glottis	According to Cormack Lehane classification four grades (1-4). The higher the grade, the higher the likelihood of difficult intubation.	180 seconds

Collaborators and Investigators

• Sponsor: Konya Meram State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2025
• Primary Completion (Actual): May 28, 2025
• Study Completion (Actual): May 28, 2025

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 31, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 111 (Shenzhen Universisty general hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No