Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy

NeuroTherapia, Inc.

Status: Completed

Conditions: Intubation; Laryngoscopy

Treatments: Device: Direct laryngoscopy; Device: GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011)

Study type: Interventional

Funder types: Other

Identifiers

NCT04701762

19-1158

Details and patient eligibility

About

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

Full 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.

Enrollment: 7,736 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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7,736 participants in 2 patient groups

videolaryngoscopy

Experimental group

Description:

Initial intubation performed using GlideScope videolaryngoscope.

Treatment:

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

conventional direct laryngoscopy

Active Comparator group

Description:

Initial intubation performed using direct laryngoscopy.

Treatment:

Device: Direct laryngoscopy