Laryngoscope Versus CMAC for Endotracheal Intubation in Patients Undergoing Emergent Airway Management

NCT01710891 | Completed Phase 4 Results DMC

• 1 other identifier: HSR 11-3338
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized controlled trial of intubation using the C-MAC video laryngoscope versus standard laryngoscopy. Patients who are going to be intubated using standard laryngoscopy will be randomized to have their first intubation attempt done using either standard laryngoscopy or the C-MAC video laryngoscope. Subsequent attempts will be at the discretion of the treating physician.

Conditions

Acute Respiratory Distress

Keywords

endotracheal intubation; direct laryngoscopy; video laryngoscopy

Outcome Measures

Primary Outcomes (2)

• First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device.

  An attempt is counted as the intubating device entering the patients mouth until it is removed. Intubation success is defined as the endotracheal tube being placed in the patients lungs as confirmed by auscultation and end tidal carbon dioxide

  During intubation procedure up to 1 hour

• Time to Intubation

  The time in seconds from the time at which the intubating device is first placed in the patient's mouth until the time of successful intubation

  From the time the first device entered the patients mouth until successful intubation up to 1 hour

Secondary Outcomes (4)

• Length of Stay

  From the time of hospital admission until discharge up to 28 days

• Aspiration Pneumonia

  from the time of hospital admission up to 28 days

• Incidence of Hypoxia

  From the start of the procedure until successful intubation up to 1 hour

• Failed Intubation

  from the start of the procedure until successful intubation up to one hour

Study Arms (2)

Direct Laryngoscopy

ACTIVE COMPARATOR

Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.

Procedure: Direct Laryngoscopy

CMAC

EXPERIMENTAL

Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance

Procedure: CMAC videolaryngoscope

Interventions

CMAC videolaryngoscope PROCEDURE

patients are intubated using the CMAC video laryngoscope

CMAC

Direct Laryngoscopy PROCEDURE

Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.

Direct Laryngoscopy

Eligibility Criteria

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

You may qualify if:

• Adult patients (age \>17) requiring emergent endotracheal intubation in the Emergency Department using direct laryngoscopy

You may not qualify if:

• Physician intends to intubate with a device other than a direct laryngoscope

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

• Driver BE, Prekker ME, Moore JC, Schick AL, Reardon RF, Miner JR. Direct Versus Video Laryngoscopy Using the C-MAC for Tracheal Intubation in the Emergency Department, a Randomized Controlled Trial. Acad Emerg Med. 2016 Apr;23(4):433-9. doi: 10.1111/acem.12933. Epub 2016 Mar 24.

  PMID: 26850232 DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Brian Driver
• Organization: MinneapolisMRF

Brian.Driver@hcmed.org

6128739528

Study Officials

• James R Miner, MD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 19, 2012
• Study Start: October 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 15, 2019
• Results First Posted: March 15, 2019

Record last verified: 2018-12

Locations

US (1)