ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01710891
Recruitment Status : Completed
First Posted : October 19, 2012
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Procedure: CMAC videolaryngoscope Procedure: Direct Laryngoscopy Phase 4

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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laryngoscope Versus CMAC for Endotracheal Intubation in Patients Undergoing Emergent Airway Management
Study Start Date : October 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of Attempts Until Successful Intubation [ Time Frame: During intubation procedure up to 1 hour ]
    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

  2. Time to Intubation [ Time Frame: From the time the first device entered the patients mouth until succsessful intubation up to 1 hour ]
    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


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: From the time of hospital admission until discharge up to 28 days ]
    The time in days from hospital admission until discharge, divided into time in the intensive care unit and total time in the hospital

  2. Aspiration Pneumonia [ Time Frame: from the time of hospital admission up to 28 days ]
    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

  3. Incidence of Hypoxia [ Time Frame: From the start of the procedure until successful intubation up to 1 hour ]
    Oxygen saturations will be recorded during the procedure, oxygen saturation less than 93% will be considered an occurrence of hypoxia

  4. Failed Intubation [ Time Frame: from the start of the procedure until sucessful intubation up to one hour ]
    Defined as the operator switching to an alternate device or intubation technique after at least one unsuccessful intubation attempt.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710891


Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
Principal Investigator: James R Miner, MD Minneapolis Medical Research Foundation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01710891     History of Changes
Other Study ID Numbers: HSR 11-3338
First Posted: October 19, 2012    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Keywords provided by Minneapolis Medical Research Foundation:
endotracheal intubation
direct laryngoscopy
video laryngoscopy