Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy

NCT04701762 | Completed Results FDA Device

• 1 other identifier: 19-1158
• Study Type: interventional
• Target: 7,736
• Locations: 1 country
• Sites: 1

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

Conditions

Intubation; Laryngoscopy

Keywords

Airway; Videolaryngoscope; Direct Laryngoscope

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intubation Failure

  From the start time of intubation to time of the end of surgery.

• Any Dental or Airway Injury

  From the start time of intubation to time of the end of surgery.

Other Outcomes (2)

• Maximum Mean Arterial Pressure

  In five minutes after intubation.

• Maximum Heart Rate (HR)

  In five minutes after intubation

Study Arms (2)

videolaryngoscopy

EXPERIMENTAL

Initial intubation performed using GlideScope videolaryngoscope.

Device: GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011)

conventional direct laryngoscopy

ACTIVE COMPARATOR

Initial intubation performed using direct laryngoscopy.

Device: Direct laryngoscopy

Interventions

GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011) 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.

videolaryngoscopy

Direct laryngoscopy 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);

conventional direct laryngoscopy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 38497992 DERIVED

Results Point of Contact

• Title: Kurt Ruetzler
• Organization: Cleveland Clinic

ruetzlk@ccf.org

216 407-4108

Study Officials

• Kurt Ruetzler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized multiple crossover design

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 8, 2021
• Study Start: March 1, 2021
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Locations

US (1)