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

NCT ID: NCT01710891

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Acute Respiratory Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Direct Laryngoscopy

Intervention Type: PROCEDURE

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

CMAC

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

Group Type: EXPERIMENTAL

CMAC videolaryngoscope

Intervention Type: PROCEDURE

patients are intubated using the CMAC video laryngoscope

Interventions

CMAC videolaryngoscope

patients are intubated using the CMAC video laryngoscope

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hennepin Healthcare Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James R Miner, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin Healthcare Research Institute

Locations

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26850232 (View on PubMed)

Other Identifiers

HSR 11-3338

Identifier Type: -

Identifier Source: org_study_id