Intubation of Patients With an Unstable Cervical Spine Using the CMAC Device

February 11, 2016 updated by: Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

A Randomized Prospective Study to Compare Tracheal Intubation With the CMAC Device to Fiberoptic Bronchoscopy in Patients With an Unstable Cervical Spine

The purpose of this study is to evaluate whether tracheal intubation with the CMAC device decreases the time required for intubation as compared to intubation with the fiberoptic bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the fiberoptic bronchoscope are currently commonly used in standard of care practices in the intubation of patients with cervical spine injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with an unstable Cervical-spine as a result of C-spine injury.
  • Patients scheduled to undergo inpatient surgical procedures under general anesthesia.
  • Willingness and ability to sign an informed consent document.
  • 18-80 years of age.
  • ASA Class I - III adults of either sex

Exclusion Criteria:

  • Patients deemed to be at significant airway risk to necessitate awake fiber optic intubation.
  • Patients with a history of oral-pharyngeal cancer or reconstructive surgery.
  • Emergency surgeries.
  • Any other conditions which may interfere with the conduct of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: CMAC Device
CMAC Intubating device time to achieve successful tracheal intubation.
Device: CMAC
CMAC Device
ACTIVE_COMPARATOR: Fiberoptic bronchoscope
Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation.
Device: Fiberoptic bronchoscope
Fiberoptic bronchoscope device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation Time (Seconds)
Time Frame: 3 minutes
Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube
3 minutes
Time to Confirm the Placement of the Tracheal Tube
Time Frame: up tp 3 minutes
It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform
up tp 3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Obtain Glottis Visualization (Seconds)
Time Frame: 1 minute
Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine.
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

April 23, 2010

First Submitted That Met QC Criteria

April 28, 2010

First Posted (ESTIMATE)

April 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00019845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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