DirEct Versus VIdeo LaryngosCopE Trial (DEVICE)

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Other: Video Laryngoscope; Other: Direct Laryngoscope

Detailed Description

Clinicians frequently perform tracheal intubation of critically ill patients in the emergency department (ED) or intensive care unit (ICU). In 10-20% of emergency tracheal intubations, clinicians are unable to intubate the trachea on the first attempt, which increases the risk of peri-intubation complications. Successful laryngoscopy and tracheal intubation requires using a laryngoscope to [1] visualize the larynx and vocal cords and [2] create a pathway through which an endotracheal tube can be advanced through the oropharynx and larynx and into the trachea.

In current clinical practice, two classes of laryngoscopes are commonly used by clinicians to 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). Clinicians use either a video laryngoscope or a direct laryngoscope as standard of care for every laryngoscopy and intubation procedure performed in current clinical practice.

Direct Laryngoscope: The Macintosh direct laryngoscope consists of a battery-containing handle and a blade with a light source. The operator achieves a direct line of sight -from the operator's eye through the mouth to the larynx and trachea - by using the laryngoscope blade to displace the tongue and elevate the epiglottis.

Video Laryngoscope: Video laryngoscopes consist of a fiberoptic camera and light source near the tip of the laryngoscope blade, which transmits images to a video screen. The position of the camera near the tip of the laryngoscope blade facilitates visualization of the larynx and trachea.

Use of a video laryngoscope and use of a direct laryngoscope are both common, standard-of-care approaches the clinicians use to perform tracheal intubation in the ED and ICU in current clinical care.

Currently, it is unknown whether use of a video laryngoscope or use of a direct laryngoscope has any effect on successful intubation on the first attempt or any other outcome. Some prior research has raised the hypothesis that using a video laryngoscope would increase clinicians' rate of successful intubation on the first attempt by facilitating the view of the larynx. Some prior research has raised the hypothesis that using a direct laryngoscope would increase clinicians' rate of successful intubation on the first attempt by facilitating a clear pathway for placement of the tube through the mouth into the trachea.

To date, 8 small single-center randomized trials and one 371-patient multicenter randomized clinical trial have been conducted under waiver of or alteration of informed consent to compare use of a video vs a direct laryngoscope in the setting of emergency tracheal intubation in the ED or ICU. Two of these trials provide the most direct preliminary data for this proposal. The "Facilitating EndotracheaL intubation by Laryngoscopy technique and apneic Oxygenation Within the ICU (FELLOW)" randomized clinical trial, conducted under waiver of informed consent, compared these two standard-of-care approaches during 150 emergency tracheal intubations at Vanderbilt University Medical Center, finding no difference in the rate of successful intubation on the first attempt between use of a video and use of a direct laryngoscope. The "McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in the Critical Care Unit (MACMAN)" randomized clinical trial among 371 critically ill adults found no difference between use of a video vs direct laryngoscope in the rate of successful intubation on the first attempt. However, a hypothesis-forming post-hoc exploratory analysis of peri-intubation complications suggested that use of a video laryngoscope may be associated with a higher rate of complications than direct laryngoscope (9.5% vs 2.8%, respectively, p=0.01). These trials were underpowered to rule out small but clinically significant differences in first pass success, and were limited to intubations performed by inexperienced trainees in one practice setting (intensive care units), but they demonstrated hypothesis-generating findings requiring validation in larger trials that reflect the full spectrum of settings, operator specialties, and operator experience levels in which emergency tracheal intubation is routinely performed.

Because of the imperative to optimize emergency tracheal intubation in clinical care, the common use of both video and direct laryngoscopes in current clinical practice, and the lack of definitive data from randomized trials to definitively inform whether use of a video laryngoscope or a direct laryngoscope effects the rate of successful intubation on the first attempt, examining whether one approach increases the odds of successful intubation on the first attempt represents an urgent research priority. To address this knowledge gap, the investigators propose to conduct a large, multicenter, randomized clinical trial comparing use of a video laryngoscope versus use of a direct laryngoscope with regard to successful intubation on the first attempt among critically ill adults undergoing tracheal intubation in the ED or ICU.

• Study Type: Interventional
• Enrollment (Actual): 1420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Ochsner Medical Center | Ochsner Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Health
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Video Laryngoscope; Laryngoscope with a camera and a video screen
Active Comparator: 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.	Other: Direct Laryngoscope; Laryngoscope without a camera or a video screen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe complications of tracheal intubation	The secondary outcome is defined as 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	from induction to 2 minutes following tracheal intubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of laryngoscopy attempts		Duration of procedure (minutes)
Duration of laryngoscopy and tracheal intubation	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.	Duration of procedure (minutes)
Number of attempts to cannulate the trachea with a bougie or an endotracheal tube		Duration of procedure (minutes)
Successful intubation on the first attempt without a severe complication	Composite of patients who meet the primary outcome (successful intubation on the first attempt) without meeting the secondary outcome (severe complications of tracheal intubation)	from induction to 2 minutes following tracheal intubation
Reason for failure to intubate on the first attempt	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	Duration of procedure (minutes)
Operator-reported aspiration		from induction to 2 minutes following tracheal intubation
Esophageal intubation		from induction to 2 minutes following tracheal intubation
Injury to the teeth		from induction to 2 minutes following tracheal intubation
ICU-free days in the first 28 days		28 days
Ventilator free days in the first 28 days		28 days
All-cause in-hospital mortality		28 days

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: University of Colorado, Denver
• Investigators: Principal Investigator: Matthew W Semler, MD, MSc, Vanderbilt University Medical Center; 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

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2022
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Critical Illness; Tracheal intubation; Video laryngoscope; Emergency Airway Management; Direct laryngoscope
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 211272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Following publication. No end date
• IPD Sharing Access Criteria: a signed data access agreement; research testing a hypothesis; a protocol that has been approved by an institutional review board; a proposal that has received approval from the principal investigator
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No