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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress
• Intervention / Treatment: Procedure: Direct Laryngoscopy; Procedure: CMAC videolaryngoscope

Detailed Description

Experimental Design and Methods:

This will be a prospective randomized controlled trial of intubation using the C-MAC video laryngoscope versus standard laryngoscopy for patients requiring emergent intubation in the Emergency Department.

Study Setting and Population:

This study will be performed at an urban county medical center with approximately 97,000 patient visits per year. Adult patients (age >17) requiring intubation will be enrolled.

Study Protocol:

All ED patients who are unable to adequately breathe on their own requiring emergent intubation for airway management will be screened for inclusion in the study. Identified patients will be deemed eligible when the need for intubation has been determined by the treating physician. Eligible patients will be placed on capnograph, cardiac, blood pressure and pulse oximetry monitors. Patients will be randomly assigned to be intubated using standard laryngoscopy with the C-MAC blade or C-MAC videolaryngoscope. Sealed envelopes containing the randomization assignment for the treatment groups will be kept at the patient's bedside in the stabilization room. Patients will be monitored by oxygen saturation, blood pressure, heart rate, and respiratory rate, which are typical for patients requiring intubation in our ED. Data will be recorded every minute by a trained research assistant at the patient's bedside. The lowest oxygen saturation during the procedure will be recorded for determination of hypoxia. Hypoxia will be defined as an oxygen saturation <93%. The number of attempts made to intubate and the total time to successful intubation will be recorded. An attempt starts when the intubating device enters the patients mouth and ends when the endotracheal tube placement is confirmed or when a new intubating device is put in the patients mouth after the previous device had been removed. Data collection includes the timing and number of breaths given via Bag-Valve-Mask and patient repositioning between the attempts. All treatments will be recorded. Data collection will continue until the patient is discharged from the Emergency Department. The patient's diagnosis at the time of discharge from the ED will be recorded. Patients' charts will be reviewed to determine the diagnosis, occurrence of aspiration pneumonia, ICU length of stay, and inpatient length of stay. Two attempts will be made to contact patients 28 days after study enrollment to determine their condition at that time.

Data Analysis:

Data will be collected by a designated research assistant during the procedure and will then be entered into an EXCEL (Microsoft Corp., Redmond, WA) database for storage. Data will be exported into STATA 10.0 (STATA Corp., College Station, TX) for further analysis. The number of attempts to successful intubation and total time to intubation will be compared using descriptive statistics. Occurrence of hypoxia and aspiration pneumonia will be compared in patients who were intubated with the C-MAC to patients intubated with standard laryngoscopy using Chi-Square tests. Oxygen saturation, ETCO2, and heart rate will be compared in both groups using multiple linear regression.

The length of stay and 28 day follow up between the two groups will be compared using Wilcoxon rank sum tests. In order to detect a 15% difference in the length of stay between the two groups, with a power of 80% and an alpha of 0.05, 100 patients will be required in each group for a total of 200 patients.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County 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:

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

Exclusion Criteria:

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

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: Direct Laryngoscopy; 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; Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.
Experimental: CMAC; Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance	Procedure: CMAC videolaryngoscope; patients are intubated using the CMAC video laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	The time in days from hospital admission until discharge.	From the time of hospital admission until discharge up to 28 days
Aspiration Pneumonia	The occurrence of aspiration pneumonia as defined by the clinical diagnosis in the patients chart and or radiographic determination of aspiration during the 28 days after the intubation procedure	from the time of hospital admission up to 28 days
Incidence of Hypoxia	Oxygen saturations will be recorded during the procedure, oxygen saturation less than 93% will be considered an occurrence of hypoxia	From the start of the procedure until successful intubation up to 1 hour
Failed Intubation	Defined as the operator switching to an alternate device or intubation technique after at least one unsuccessful intubation attempt.	from the start of the procedure until successful intubation up to one hour

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (Estimate): October 19, 2012

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: endotracheal intubation; video laryngoscopy; direct laryngoscopy
• Other Study ID Numbers: HSR 11-3338

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No