Trial Outcomes & Findings for DirEct Versus VIdeo LaryngosCopE Trial (NCT NCT05239195)

NCT ID: NCT05239195

Last Updated: 2024-08-19

Results Overview

The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and EITHER a single insertion of an endotracheal tube into the mouth OR a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1420 participants
• Primary outcome timeframe: Duration of procedure (minutes)
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Video Laryngoscope Group For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Overall Study STARTED	707	713
Overall Study COMPLETED	705	712
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Video Laryngoscope Group For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Overall Study After enrollment, discovered to be a person experiencing incarceration.	2	1

Baseline Characteristics

DirEct Versus VIdeo LaryngosCopE Trial

Baseline characteristics by cohort

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen	Total n=1417 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	55 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	240 Participants n=5 Participants	258 Participants n=7 Participants	498 Participants n=5 Participants
Sex: Female, Male Male	465 Participants n=5 Participants	454 Participants n=7 Participants	919 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Non-Hispanic White	360 Participants n=5 Participants	346 Participants n=7 Participants	706 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Non-Hispanic Black	166 Participants n=5 Participants	167 Participants n=7 Participants	333 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Hispanic	101 Participants n=5 Participants	94 Participants n=7 Participants	195 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Other	61 Participants n=5 Participants	84 Participants n=7 Participants	145 Participants n=5 Participants
Race/Ethnicity, Customized Race or ethnic group · Not reported	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	705 participants n=5 Participants	712 participants n=7 Participants	1417 participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of procedure (minutes)

The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and EITHER a single insertion of an endotracheal tube into the mouth OR a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth.

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Number of Intubations With Successful Intubation on the First Attempt	600 Participants	504 Participants

SECONDARY outcome

Timeframe: from induction to 2 minutes following tracheal intubation

The secondary outcome is defined as the number of patients who experienced one or more of the following occurring between induction and 2 minutes after successful intubation:

• Severe hypoxemia (lowest oxygen saturation measured by pulse oximetry < 80%);
• Severe hypotension (systolic blood pressure < 65 mm Hg or new or increased vasopressor administration);
• Cardiac arrest not resulting in death within 1 hour of intubation; or
• Cardiac arrest resulting in death within 1 hour of induction

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Number of Participants With Severe Complications of Tracheal Intubation	151 Participants	149 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of procedure (minutes)

The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of an endotracheal tube or tracheostomy tube in the trachea.

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Duration of Laryngoscopy and Tracheal Intubation	38 Seconds Interval 26.0 to 60.0	46 Seconds Interval 30.0 to 83.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of procedure (minutes)

Population: A subset of patients were missing this data variable.

Outcome measures

Measure	Video Laryngoscope Group n=704 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=706 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Number of Laryngoscopy Attempts Number of times a laryngoscope entered the patient's mouth (reported by observer) - 1	636 Participants	546 Participants
Number of Laryngoscopy Attempts Number of times a laryngoscope entered the patient's mouth (reported by observer) - 2	54 Participants	127 Participants
Number of Laryngoscopy Attempts Number of times a laryngoscope entered the patient's mouth (reported by observer) - 3+	14 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of procedure (minutes)

Population: Data was not available for entire patient population.

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=707 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube Bougie - 3+	6 number of events	27 number of events
Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube Endotracheal Tube - 1	646 number of events	620 number of events
Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube Endotracheal Tube - 2	43 number of events	66 number of events
Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube Endotracheal Tube - 3+	15 number of events	19 number of events
Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube Bougie - 0	364 number of events	330 number of events
Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube Bougie - 1	316 number of events	317 number of events
Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube Bougie - 2	19 number of events	33 number of events

OTHER_PRE_SPECIFIED outcome

Timeframe: from induction to 2 minutes following tracheal intubation

This outcome reports the number of participants that experienced successful intubation on the first attempt without experiencing complications, a composite of two independent outcomes: successful intubation on the first attempt (the primary outcome of the trial) and severe complication (the secondary outcome of the trial).

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Successful Intubation on the First Attempt Without a Severe Complication	484 Participants	420 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of procedure (minutes)

Providers could give more than one reason for failure to intubate on the first attempt for each intubation (not mutually exclusive). In addition, data on the reason for failure to intubate on the first attempt was missing for 23 patients in the video laryngoscope group and 40 patients in the direct laryngoscope group.

Reason for failure among those who did not meet the primary outcome (successful intubation on the first attempt):

• Inadequate view of the larynx
• Inability to intubate the trachea with an endotracheal tube
• Inability to cannulate the trachea with a bougie
• Attempt aborted due to change in patient condition (e.g., worsening hypoxemia, hypotension, bradycardia, vomiting, bleeding)
• Technical failure of the laryngoscope (e.g., battery, light source, camera, screen)
• Other
• Not Reported

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Reason for Failure to Intubate on the First Attempt Inadequate view of the larynx	26 Participants	123 Participants
Reason for Failure to Intubate on the First Attempt Inability to intubate the trachea with an endotracheal tube	44 Participants	32 Participants
Reason for Failure to Intubate on the First Attempt Inability to cannulate the trachea with a bougie	7 Participants	19 Participants
Reason for Failure to Intubate on the First Attempt Attempt aborted due to change in patient condition	2 Participants	14 Participants
Reason for Failure to Intubate on the First Attempt Technical failure of the laryngoscope (e.g., battery, light source, camera, screen)	2 Participants	4 Participants
Reason for Failure to Intubate on the First Attempt Other	13 Participants	10 Participants
Reason for Failure to Intubate on the First Attempt Not Reported	23 Participants	40 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: from induction to 2 minutes following tracheal intubation

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Operator-reported Aspiration	7 Participants	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: from induction to 2 minutes following tracheal intubation

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Esophageal Intubation	6 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: from induction to 2 minutes following tracheal intubation

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Injury to the Teeth	3 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
ICU-free Days in the First 28 Days	20 days Interval 0.0 to 25.0	19 days Interval 0.0 to 24.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
Ventilator Free Days in the First 28 Days	24 days Interval 0.0 to 26.0	23 days Interval 0.0 to 26.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Outcome measures

Measure	Video Laryngoscope Group n=705 Participants For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen	Direct Laryngoscope Group n=712 Participants For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen
All-cause In-hospital Mortality	184 Participants	191 Participants

Adverse Events

Video Laryngoscope Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 184 deaths

Direct Laryngoscope Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 191 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan D Casey, MD, MSc

Vanderbilt University Medical Center

Phone: 615-875-4681

Email: Jonathan.d.Casey@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place