DirEct Versus VIdeo LaryngosCopE Trial
DEVICE
1 other identifier
interventional
1,420
1 country
12
Brief Summary
Clinicians perform rapid sequence induction, laryngoscopy, and tracheal intubation for more than 5 million critically ill adults as a part of clinical care each year in the United States. Failure to intubate the trachea on the first attempt occurs in more than 10% of all tracheal intubation procedures performed in the emergency department (ED) and intensive care unit (ICU). Improving clinicians rate of intubation on the first attempt could reduce the risk of serious procedural complications. In current clinical practice, two classes of laryngoscopes are commonly used to help clinicians view the larynx while intubating the trachea: a video laryngoscope (equipped with a camera and a video screen) and a direct laryngoscope (not equipped with a camera or video screen). For nearly all laryngoscopy and intubation procedures performed in current clinical practice, clinicians use either a video or a direct laryngoscope. Prior research has shown that use of a video laryngoscope improves the operator's view of the larynx compared to a direct laryngoscope. Whether use of a video laryngoscope increases the likelihood of successful intubation on the first attempt remains uncertain. A better understanding of the comparative effectiveness of these two common, standard-of-care approaches to laryngoscopy and intubation could improve the care clinicians deliver and patient outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedStudy Start
First participant enrolled
March 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2022
CompletedResults Posted
Study results publicly available
August 19, 2024
CompletedAugust 19, 2024
March 1, 2024
8 months
February 3, 2022
August 25, 2023
March 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Intubations With Successful Intubation on the First Attempt
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.
Duration of procedure (minutes)
Secondary Outcomes (1)
Number of Participants With Severe Complications of Tracheal Intubation
from induction to 2 minutes following tracheal intubation
Other Outcomes (11)
Duration of Laryngoscopy and Tracheal Intubation
Duration of procedure (minutes)
Number of Laryngoscopy Attempts
Duration of procedure (minutes)
Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube
Duration of procedure (minutes)
- +8 more other outcomes
Study Arms (2)
Video Laryngoscope Group
ACTIVE COMPARATORFor 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.
Direct Laryngoscope Group
ACTIVE COMPARATORFor 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.
Interventions
Eligibility Criteria
You may qualify if:
- Patient is located in a participating unit.
- Planned procedure is orotracheal intubation using a laryngoscope.
- Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit.
You may not qualify if:
- Patient is known to be less than 18 years old.
- Patient is known to be pregnant.
- Patient is known to be a prisoner.
- Immediate need for tracheal intubation precludes safe performance of study procedures.
- Operator has determined that use of a video laryngoscope or use of a direct laryngoscope is required or contraindicated for the optimal care of the patient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
UAB Hospital
Birmingham, Alabama, 35233, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
Ochsner Medical Center | Ochsner Health System
New Orleans, Louisiana, 70112, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Baylor Scott & White Health
Temple, Texas, 76508, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (2)
Prekker ME, Driver BE, Trent SA, Resnick-Ault D, Seitz KP, Russell DW, Gaillard JP, Latimer AJ, Ghamande SA, Gibbs KW, Vonderhaar DJ, Whitson MR, Barnes CR, Walco JP, Douglas IS, Krishnamoorthy V, Dagan A, Bastman JJ, Lloyd BD, Gandotra S, Goranson JK, Mitchell SH, White HD, Palakshappa JA, Espinera A, Page DB, Joffe A, Hansen SJ, Hughes CG, George T, Herbert JT, Shapiro NI, Schauer SG, Long BJ, Imhoff B, Wang L, Rhoads JP, Womack KN, Janz DR, Self WH, Rice TW, Ginde AA, Casey JD, Semler MW; DEVICE Investigators and the Pragmatic Critical Care Research Group. Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2023 Aug 3;389(5):418-429. doi: 10.1056/NEJMoa2301601. Epub 2023 Jun 16.
PMID: 37326325DERIVEDPrekker ME, Driver BE, Trent SA, Resnick-Ault D, Seitz K, Russell DW, Gandotra S, Gaillard JP, Gibbs KW, Latimer A, Whitson MR, Ghamande S, Vonderhaar DJ, Walco JP, Hansen SJ, Douglas IS, Barnes CR, Krishnamoorthy V, Bastman JJ, Lloyd BD, Robison SW, Palakshappa JA, Mitchell S, Page DB, White HD, Espinera A, Hughes C, Joffe AM, Herbert JT, Schauer SG, Long BJ, Imhoff B, Wang L, Rhoads JP, Womack KN, Janz D, Self WH, Rice TW, Ginde AA, Casey JD, Semler MW; DEVICE investigators and the Pragmatic Critical Care Research Group. DirEct versus VIdeo LaryngosCopE (DEVICE): protocol and statistical analysis plan for a randomised clinical trial in critically ill adults undergoing emergency tracheal intubation. BMJ Open. 2023 Jan 13;13(1):e068978. doi: 10.1136/bmjopen-2022-068978.
PMID: 36639210DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan D Casey, MD, MSc
- Organization
- Vanderbilt University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew W Semler, MD, MSc
Vanderbilt University Medical Center
- PRINCIPAL INVESTIGATOR
Adit A Ginde, MD, MPH
University of Colorado, Denver
- STUDY CHAIR
Matthew E Prekker, MD, MPH
Hennepin County Medical Center, Minneapolis
- STUDY CHAIR
Stacy A Trent, MD, MPH
Denver Health Medical Center
- STUDY CHAIR
Brian E Driver, MD
Hennepin County Medical Center, Minneapolis
- STUDY DIRECTOR
Jonathan D Casey, MD, MSc
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 3, 2022
First Posted
February 14, 2022
Study Start
March 19, 2022
Primary Completion
November 17, 2022
Study Completion
December 16, 2022
Last Updated
August 19, 2024
Results First Posted
August 19, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Following publication. No end date
- Access Criteria
- 1. a signed data access agreement 2. research testing a hypothesis 3. a protocol that has been approved by an institutional review board 4. a proposal that has received approval from the principal investigator
Following publication, individual patient data will be made available for sharing to researchers with 1) a signed data access agreement, 2) research testing a hypothesis, 3) a protocol that has been approved by an institutional review board, and 4) a proposal that has received approval from the principal investigator.