Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy

NCT ID: NCT04701762

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7736 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-12-23

Brief Summary

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

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.

Conditions

Intubation; Laryngoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

videolaryngoscopy

Initial intubation performed using GlideScope videolaryngoscope.

Group Type: EXPERIMENTAL

GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011)

Intervention Type: DEVICE

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.

conventional direct laryngoscopy

Initial intubation performed using direct laryngoscopy.

Group Type: ACTIVE_COMPARATOR

Direct laryngoscopy

Intervention Type: DEVICE

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);

Interventions

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.

Intervention Type: 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);

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurt Ruetzler, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Ruetzler K, Bustamante S, Schmidt MT, Almonacid-Cardenas F, Duncan A, Bauer A, Turan A, Skubas NJ, Sessler DI; Collaborative VLS Trial Group. Video Laryngoscopy vs Direct Laryngoscopy for Endotracheal Intubation in the Operating Room: A Cluster Randomized Clinical Trial. JAMA. 2024 Apr 16;331(15):1279-1286. doi: 10.1001/jama.2024.0762.

Reference Type: DERIVED

PMID: 38497992 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-1158

Identifier Type: -

Identifier Source: org_study_id