Trial Outcomes & Findings for Intubation of Patients With an Unstable Cervical Spine Using the CMAC Device (NCT NCT01113723)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

140 participants

Primary outcome timeframe

3 minutes

Results posted on

2016-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	CMAC Device CMAC CMAC: CMAC Device	Fiberoptic Bronchoscope Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
Overall Study STARTED	70	70
Overall Study COMPLETED	70	70
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CMAC Device n=70 Participants CMAC CMAC: CMAC Device	Fiberoptic Bronchoscope n=70 Participants Fiberoptic bronchoscope Fiberoptic bronchoscope: Fiberoptic bronchoscope device	Total n=140 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 12 • n=5 Participants	50 years STANDARD_DEVIATION 12 • n=7 Participants	53 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	38 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	32 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants	70 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 minutes

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

Outcome measures

Outcome measures
Measure	CMAC Device n=70 Participants CMAC: CMAC Device	Flexible Fiberoptic Scope (FFS) n=70 Participants the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
Intubation Time (Seconds)	35 Seconds Standard Deviation 22	59 Seconds Standard Deviation 36

PRIMARY outcome

Timeframe: up tp 3 minutes

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

Outcome measures

Outcome measures
Measure	CMAC Device n=70 Participants CMAC: CMAC Device	Flexible Fiberoptic Scope (FFS) n=70 Participants the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
Time to Confirm the Placement of the Tracheal Tube	62 Seconds Standard Deviation 31	99 Seconds Standard Deviation 38

SECONDARY outcome

Timeframe: 1 minute

Population: Time to Obtain Glottis Visualization (Seconds) Glottic visualization during the beginning of the intubation procedure.

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.

Outcome measures

Outcome measures
Measure	CMAC Device n=70 Participants CMAC: CMAC Device	Flexible Fiberoptic Scope (FFS) n=70 Participants the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
Time to Obtain Glottis Visualization (Seconds)	32 Seconds Standard Deviation 32	16 Seconds Standard Deviation 14

Adverse Events

CMAC Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Flexible Fiberoptic Scope (FFS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roya Yumul, M.D., Ph.D.

Department of Anesthesiology, Cedars-Sinai Medical Center

Phone: 310-423-5841

Email: ([email protected])

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place