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Clinical Trials/NCT01113723
NCT01113723
Completed
Phase 4

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

Cedars-Sinai Medical Center1 site in 1 country140 target enrollmentDecember 2009
ConditionsLaminectomy

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Laminectomy
Sponsor
Cedars-Sinai Medical Center
Enrollment
140
Locations
1
Primary Endpoint
Time to Confirm the Placement of the Tracheal Tube
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
February 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roya Yumul, M.D.,PhD.

Residency program director, Department of anesthesiology

Cedars-Sinai Medical Center

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Intubation Time (Seconds)

Time Frame: 3 minutes

Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube

Secondary Outcomes

  • Time to Obtain Glottis Visualization (Seconds)(1 minute)

Study Sites (1)

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