Trial Outcomes & Findings for Comparative Effectiveness of Intubating Devices in the Morbidly Obese (NCT NCT01114945)

Results Overview

Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

121 participants

Primary outcome timeframe

up to 3 minutes

Results posted on

2016-04-06

Participant Flow

Obese patients (ASA II-III) undergoing bariatric surgery (e.g., laparoscopic gastric band placement, laparoscopic Roux-EN-Y gastric bypass laparoscopic) requiring orotracheal intubation were randomly assigned to one of four study groups. Enrollment from May 2010 to February 2012.

Participant milestones

Participant milestones
Measure	Video-Mac Video-Mac device	GlideScope GlideScope device	McGrath MacGrath	Direct Macintosh Laryngoscopy Direct Macintosh Laryngoscopy (DL)
Overall Study STARTED	30	30	30	31
Overall Study COMPLETED	30	30	30	31
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effectiveness of Intubating Devices in the Morbidly Obese

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Direct Macintosh Laryngoscopy n=31 Participants Direct Macintosh Laryngoscope device	Video-Mac n=30 Participants Video-Mac device	GlideScope n=30 Participants GlideScope device	McGrath n=30 Participants MacGrath device	Total n=121 Participants Total of all reporting groups
Age, Continuous	46 Years STANDARD_DEVIATION 12 • n=5 Participants	44 Years STANDARD_DEVIATION 12 • n=7 Participants	45 Years STANDARD_DEVIATION 12 • n=5 Participants	45 Years STANDARD_DEVIATION 12 • n=4 Participants	45 Years STANDARD_DEVIATION 12 • n=21 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	23 Participants n=5 Participants	20 Participants n=4 Participants	89 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants	32 Participants n=21 Participants
Body Mass Index (BMI)	42 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants	43 kg/m^2 STANDARD_DEVIATION 8 • n=7 Participants	43 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants	41 kg/m^2 STANDARD_DEVIATION 6 • n=4 Participants	42 kg/m^2 STANDARD_DEVIATION 6 • n=21 Participants

PRIMARY outcome

Timeframe: up to 3 minutes

Population: Times following initial insertion of laryngoscope blade: to obtain glottic view (sec) to placement of tracheal tube (sec) to confirm with CO2 waveform (sec)

Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.

Outcome measures

Outcome measures
Measure	Direct Macintosh Laryngoscopy n=31 Participants Direct Macintosh Laryngoscopy (DL)	Video-Mac n=30 Participants Video-Mac device	GlideScope n=30 Participants GlideScope device	McGrath n=30 Participants MacGrath device
Intubation Time Using a Stop Watch Time to placement of tracheal tube	43 Seconds Standard Deviation 44	22 Seconds Standard Deviation 15	45 Seconds Standard Deviation 32	40 Seconds Standard Deviation 32
Intubation Time Using a Stop Watch Time to confirm with CO2 waveform	70 Seconds Standard Deviation 43	49 Seconds Standard Deviation 25	69 Seconds Standard Deviation 34	62 Seconds Standard Deviation 31

PRIMARY outcome

Timeframe: up to 1 minute

It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view. Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery

Outcome measures

Outcome measures
Measure	Direct Macintosh Laryngoscopy n=31 Participants Direct Macintosh Laryngoscopy (DL)	Video-Mac n=30 Participants Video-Mac device	GlideScope n=30 Participants GlideScope device	McGrath n=30 Participants MacGrath device
Time to Obtain Glottis Visualization (Seconds)	20 Seconds Standard Deviation 28	9 Seconds Standard Deviation 8	12 Seconds Standard Deviation 9	10 Seconds Standard Deviation 9

PRIMARY outcome

Timeframe: up to 1 minute

POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%. View of the glottic opening (0-100%) during the intubation process.

Outcome measures

Outcome measures
Measure	Direct Macintosh Laryngoscopy n=31 Participants Direct Macintosh Laryngoscopy (DL)	Video-Mac n=30 Participants Video-Mac device	GlideScope n=30 Participants GlideScope device	McGrath n=30 Participants MacGrath device
Percentage of Glottic Opening (POGO) [%]	57 percentage of glottis opening Standard Deviation 41	84 percentage of glottis opening Standard Deviation 20	87 percentage of glottis opening Standard Deviation 16	91 percentage of glottis opening Standard Deviation 11

PRIMARY outcome

Timeframe: Up to 1 minute

Population: Cormack Lehane score (grade:1/2/3/4 \[n\])

Cormack Lehane score classification: Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible

Outcome measures

Outcome measures
Measure	Direct Macintosh Laryngoscopy n=31 Participants Direct Macintosh Laryngoscopy (DL)	Video-Mac n=30 Participants Video-Mac device	GlideScope n=30 Participants GlideScope device	McGrath n=30 Participants MacGrath device
Glottis View Using the Cormack Lehane Score Grade 1	12 participants	16 participants	18 participants	23 participants
Glottis View Using the Cormack Lehane Score Grade 4	6 participants	0 participants	0 participants	0 participants
Glottis View Using the Cormack Lehane Score Grade 2	8 participants	12 participants	10 participants	7 participants
Glottis View Using the Cormack Lehane Score Grade 3	5 participants	2 participants	2 participants	0 participants

Adverse Events

Video-Mac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GlideScope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

McGrath

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Direct Macintosh 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

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

Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles

Phone: 310-423-5841

Email: ([email protected])

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place