Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy

Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial

The investigators will evaluate the endotracheal intubation using video laryngoscopy versus conventional direct laryngoscopy on intubation success, quantified by the number of intubation attempts. The question is important because video laryngoscopes are more expensive than conventional direct laryngoscopes. The additional cost might be justified if video systems improve intubation success and reduce airway trauma. But if they do not, the extra cost would not be justified

Study Overview

• Status: Completed
• Conditions: Intubation; Laryngoscopy
• Intervention / Treatment: Device: Direct laryngoscopy; Device: GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011)

Detailed Description

The investigators propose to enroll participants scheduled for elective or emergent cardiac, thoracic, or vascular surgery in the designated operating room suite who require endotracheal intubation for general anesthesia.

A cluster randomized multiple crossover design is used for this trial. The cardiac surgical suites will be divided into 2 sets of 11 operating rooms. Each set is treated as a unit and randomized to receive video or direct laryngoscopy in 1-week blocks, always with 1 set randomized to each approach. For analysis, each operating room within a set will be considered a separate cluster. Randomization will be conducted weekly on a 1:1 unstratified basis, using computer-generated codes maintained in a web-based system. Investigators access these codes a day before each new treatment block begins.

• Study Type: Interventional
• Enrollment (Actual): 7736
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elective or emergent surgery requiring oral endotracheal intubation for general anesthesia.

Exclusion Criteria:

• The attending anesthesiologist prefers a specific approach for a particular patient
• Awake fiberoptic intubation is clinically indicated
• Insertion of double-lumen tube.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: videolaryngoscopy; Initial intubation performed using GlideScope videolaryngoscope.	Device: GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011); After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, Washington 98011) is an FDA-cleared commercially available portable videolaryngoscope.
Active Comparator: conventional direct laryngoscopy; Initial intubation performed using direct laryngoscopy.	Device: Direct laryngoscopy; After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.	Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated.	From the start time of intubation to time of the end of surgery up to 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation Failure	Intubation failure is defined by the responsible clinician switching to an alternative laryngoscopy device for any reason at any time, or by more than 3 intubation attempts.	From the start time of intubation to time of the end of surgery.
Any Dental or Airway Injury	Airway injury is defined as any bleeding or apparent injury to the lips, mouth, pharynx, vocal cords, or other airway structures recorded by the anesthesia team. Dental injury is defined as any apparent injury to the teeth as recorded by the anesthesia team.	From the start time of intubation to time of the end of surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Mean Arterial Pressure	Maximum mean arterial pressure (MAP) in the five minutes after intubation	In five minutes after intubation.
Maximum Heart Rate (HR)	Maximum heart rate in the five minutes after intubation	In five minutes after intubation

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Kurt Ruetzler, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Direct Laryngoscope; Airway; Videolaryngoscope
• Other Study ID Numbers: 19-1158

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No