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

NCT01113723 | Completed Phase 4 Results DMC

• 1 other identifier: Pro00019845
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Laminectomy

Keywords

C-MAC; Fiberoptic bronchoscope; Laryngoscopy; Cervical spine injury; Glottic view; Tracheal intubation

Outcome Measures

Primary Outcomes (2)

• Intubation Time (Seconds)

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

  3 minutes

• Time to Confirm the Placement of the Tracheal Tube

  It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform

  up tp 3 minutes

Secondary Outcomes (1)

• Time to Obtain Glottis Visualization (Seconds)

  1 minute

Study Arms (2)

CMAC Device

OTHER

CMAC Intubating device time to achieve successful tracheal intubation.

Device: CMAC

Fiberoptic bronchoscope

ACTIVE COMPARATOR

Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation.

Device: Fiberoptic bronchoscope

Interventions

Fiberoptic bronchoscope DEVICE

Fiberoptic bronchoscope device

Fiberoptic bronchoscope

CMAC DEVICE

CMAC Device

CMAC Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age.
• ASA Class I - III adults of either sex

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Results Point of Contact

• Title: Roya Yumul, M.D., Ph.D.
• Organization: Department of Anesthesiology, Cedars-Sinai Medical Center

(Roya.Yumul@cshs.org)

310-423-5841

Study Officials

• Roya Yumul, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency program director, Department of anesthesiology

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 30, 2010
• Study Start: December 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 9, 2016
• Results First Posted: March 9, 2016

Record last verified: 2016-02

Locations

US (1)