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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06349005
Other study ID # 111
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 10, 2024
Est. completion date September 1, 2024

Study information

Verified date March 2024
Source Konya Meram State Hospital
Contact Betul Kozanhan, M.D.
Phone (0332) 310 50 00
Email betulkozanhan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 112
Est. completion date September 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Tracheal intubation using Storz VL
Video-assisted intubation technique using Storz VL
Tracheal intubation using Macintosh laryngoscopy
Traditional intubation technique using Macintosh laryngoscopy
Tracheal intubation using MacGrath VL
Video-assisted intubation technique using MacGrath VL
Tracheal intubation using EzVision VL
Video-assisted intubation technique using EzVision VL

Locations

Country Name City State
Turkey Betul Kozanhan Konya

Sponsors (1)

Lead Sponsor Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemodynamic response Change from baseline invasive blood pressure Change from baseline Systolic or Diastolic or mean Blood Pressure at 10 minutes
Primary Hemodynamic response Change from baseline heart rate Change from baseline heart rate at 10 minutes
Secondary 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
Secondary 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
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