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

NCT ID: NCT01113723

Last Updated: 2016-03-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Laminectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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CMAC Device

CMAC Intubating device time to achieve successful tracheal intubation.

Group Type OTHER

CMAC

Intervention Type DEVICE

CMAC Device

Fiberoptic bronchoscope

Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation.

Group Type ACTIVE_COMPARATOR

Fiberoptic bronchoscope

Intervention Type DEVICE

Fiberoptic bronchoscope device

Interventions

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Fiberoptic bronchoscope

Fiberoptic bronchoscope device

Intervention Type DEVICE

CMAC

CMAC Device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Roya Yumul, M.D.,PhD.

Residency program director, Department of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roya Yumul, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00019845

Identifier Type: -

Identifier Source: org_study_id

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