Trial Outcomes & Findings for Comparison of Storz C-MAC and D-MAC Orotracheal Intubation Systems in Morbidly Obese Patients (NCT NCT01556061)

Results Overview

Time taken for successful placement of endotracheal tube after a successful laryngoscopy. Typically a successful laryngoscopy will range from few seconds to no more than 90 seconds. A successful intubation will not range more than 90 seconds.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

90 seconds

Results posted on

2014-05-26

Participant Flow

The dates of the recruitment period were 6/1/11 -12/12/11. Patients were recruited in the Preoperative Day Surgery area and preoperative Holding Unit.

No enrolled patients were excluded from the study.

Participant milestones

Participant milestones
Measure	C-MAC First, Then DMAC Video Laryngoscopy C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.	D-MAC First, Then CMAC Video Laryngoscopy D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Storz C-MAC and D-MAC Orotracheal Intubation Systems in Morbidly Obese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C-MAC First, Then DMAC Video Laryngoscopy n=25 Participants C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.	D-MAC First, Then C-MAC Video Laryngoscopy n=25 Participants D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42.4 years STANDARD_DEVIATION 11.0 • n=5 Participants	46.2 years STANDARD_DEVIATION 11.2 • n=7 Participants	44.3 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 seconds

Population: The unit of measure of time in seconds from D-MAC larynogoscopy to intubation in the (C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy) group and from C-MAC laryngoscopy to intubation in the (D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy) group.

Time taken for successful placement of endotracheal tube after a successful laryngoscopy. Typically a successful laryngoscopy will range from few seconds to no more than 90 seconds. A successful intubation will not range more than 90 seconds.

Outcome measures

Outcome measures
Measure	C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy n=25 Participants C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.	D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy n=25 Participants D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
Time for Intubation	9 seconds Interval 5.85 to 13.95	7.3 seconds Interval 5.35 to 13.45

SECONDARY outcome

Timeframe: 30 seconds

Patients underwent laryngoscopy first with their assigned randomized laryngoscope. Time measured was from the time from the moment the anesthesiologist had the laryngoscope in hand to time to optimal visualization of vocal cords.

Outcome measures

Outcome measures
Measure	C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy n=25 Participants C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.	D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy n=25 Participants D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
First Laryngoscopy	6.7 seconds Interval 4.45 to 9.7	7.2 seconds Interval 4.82 to 9.95

SECONDARY outcome

Timeframe: 30 seconds

A second laryngoscopy will be performed in patients with the video laryngoscope from the other group. Patients will be intubated after second laryngoscopy with with this same video laryngoscope.

Outcome measures

Outcome measures
Measure	C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy n=25 Participants C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.	D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy n=25 Participants D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
Second Laryngoscopy	6.7 seconds Interval 4.2 to 9.1	5.5 seconds Interval 4.04 to 9.4

Adverse Events

C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DMAC Laryngoscopy First, Then C-MAC Video Laryngoscopy

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

Dr. Davide Cattano MD PhD

University of Texas at Houston Medical School/ Dept. of Anesthesiology

Phone: 713-500-6235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place