Trial Outcomes & Findings for Laryngoscope Versus CMAC for Endotracheal Intubation in Patients Undergoing Emergent Airway Management (NCT NCT01710891)

Results Overview

An attempt is counted as the intubating device entering the patients mouth until it is removed. Intubation success is defined as the endotracheal tube being placed in the patients lungs as confirmed by auscultation and end tidal carbon dioxide

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

198 participants

Primary outcome timeframe

During intubation procedure up to 1 hour

Results posted on

2019-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Direct Laryngoscopy Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood. Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.	CMAC Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope
Overall Study STARTED	95	103
Overall Study COMPLETED	95	103
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laryngoscope Versus CMAC for Endotracheal Intubation in Patients Undergoing Emergent Airway Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Direct Laryngoscopy n=95 Participants Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood. Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.	CMAC n=103 Participants Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope	Total n=198 Participants Total of all reporting groups
Age, Continuous	51.6 years n=5 Participants	52.6 years n=7 Participants	52.1 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	41 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	62 Participants n=7 Participants	125 Participants n=5 Participants
Region of Enrollment United States	95 participants n=5 Participants	103 participants n=7 Participants	198 participants n=5 Participants

PRIMARY outcome

Timeframe: During intubation procedure up to 1 hour

An attempt is counted as the intubating device entering the patients mouth until it is removed. Intubation success is defined as the endotracheal tube being placed in the patients lungs as confirmed by auscultation and end tidal carbon dioxide

Outcome measures

Outcome measures
Measure	Direct Laryngoscopy n=95 Participants Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood. Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.	CMAC n=103 Participants Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope
First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device.	86.3 percentage of participants Interval 79.2 to 93.4	92.2 percentage of participants Interval 87.0 to 97.5

PRIMARY outcome

Timeframe: From the time the first device entered the patients mouth until successful intubation up to 1 hour

The time in seconds from the time at which the intubating device is first placed in the patient's mouth until the time of successful intubation

Outcome measures

Outcome measures
Measure	Direct Laryngoscopy n=95 Participants Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood. Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.	CMAC n=103 Participants Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope
Time to Intubation	58 Seconds Interval 49.0 to 69.0	61 Seconds Interval 46.0 to 77.0

SECONDARY outcome

Timeframe: From the time of hospital admission until discharge up to 28 days

The time in days from hospital admission until discharge.

Outcome measures

Outcome measures
Measure	Direct Laryngoscopy n=95 Participants Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood. Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.	CMAC n=103 Participants Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope
Length of Stay	9.1 Days Interval 6.6 to 11.5	8.5 Days Interval 6.6 to 10.3

SECONDARY outcome

Timeframe: from the time of hospital admission up to 28 days

The occurrence of aspiration pneumonia as defined by the clinical diagnosis in the patients chart and or radiographic determination of aspiration during the 28 days after the intubation procedure

Outcome measures

Outcome measures
Measure	Direct Laryngoscopy n=90 Participants Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood. Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.	CMAC n=96 Participants Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope
Aspiration Pneumonia	12.2 Percentage of Aspiration Pneumonia Interval 5.3 to 19.1	7.2 Percentage of Aspiration Pneumonia Interval 2.0 to 12.6

SECONDARY outcome

Timeframe: From the start of the procedure until successful intubation up to 1 hour

Oxygen saturations will be recorded during the procedure, oxygen saturation less than 93% will be considered an occurrence of hypoxia

Outcome measures

Outcome measures
Measure	Direct Laryngoscopy n=95 Participants Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood. Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.	CMAC n=103 Participants Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope
Incidence of Hypoxia	27.3 Percentage of Hypoxemia Interval 18.4 to 36.3	25.2 Percentage of Hypoxemia Interval 16.9 to 33.6

SECONDARY outcome

Timeframe: from the start of the procedure until successful intubation up to one hour

Defined as the operator switching to an alternate device or intubation technique after at least one unsuccessful intubation attempt.

Outcome measures

Outcome measures
Measure	Direct Laryngoscopy n=13 Participants Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood. Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.	CMAC n=8 Participants Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope
Failed Intubation	61.5 percentage of participants	25 percentage of participants

Adverse Events

Direct Laryngoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CMAC

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

Brian Driver

MinneapolisMRF

Phone: 6128739528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place