Trial Outcomes & Findings for Intubation of Morbidly Obese Patients. A Clinical Trial, Comparing Glide Scope ® With Fastrach TM (NCT NCT01237080)

Results Overview

The intubation attempt was considered a failure if the GS or the FT was removed from the patient's mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

please see description

Results posted on

2013-02-20

Participant Flow

The study was conducted from September 2010 to January 2011. Patients were recuted from two hospitals.

Exclusion: severe mental disorder, greater alcohol consumption than recommended by the Danish Health Authority, drug abuse, previously impossible mask ventilation or intubation with the GS and/or FT, the need for RSI and if the anaesthetist responsible determined that the patient should be treated differently than described in the protocol.

Participant milestones

Participant milestones
Measure	Fastrach 50 persons beeing intubated using the Fastrach.	GlideScope 50 persons beeing intubated using the GlideScope.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intubation of Morbidly Obese Patients. A Clinical Trial, Comparing Glide Scope ® With Fastrach TM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fastrach n=50 Participants 50 persons beeing intubated using the Fastrach.	GlideScope n=50 Participants 50 persons beeing intubated using the GlideScope.	Total n=100 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	50 Participants n=5 Participants	50 Participants n=7 Participants	100 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 years FULL_RANGE NA • n=5 Participants	43 years FULL_RANGE NA • n=7 Participants	42 years FULL_RANGE 999999 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	43 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment Denmark	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: please see description

The intubation attempt was considered a failure if the GS or the FT was removed from the patient's mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).

Outcome measures

Outcome measures
Measure	Fastrach n=50 Participants 50 persons beeing intubated using the Fastrach.	GlideScope n=50 Participants 50 persons beeing intubated using the GlideScope.
Number of Patients Intubated in the First Attempt	42 participants	46 participants

PRIMARY outcome

Timeframe: From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.

Population: The sample size was calculated to 40 in each group (50 patients were included in each group): minimum relevant difference in intubation time of 20 s and a standard deviation of 28 s. A significance level of 0.05 and an acceptable risk of Type 2 error of 0.1 were used.

Outcome measures

Outcome measures
Measure	Fastrach n=50 Participants 50 persons beeing intubated using the Fastrach.	GlideScope n=50 Participants 50 persons beeing intubated using the GlideScope.
Time to Intubate	61 sec Interval 46.0 to 76.0	49 sec Interval 40.0 to 57.0

SECONDARY outcome

Timeframe: measured on the monitor

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: inspection during intubation and one hour postop.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured immediately on a visual analogue scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: detected immediately

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one hour postoperative.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one hour postoperative

Outcome measures

Outcome data not reported

Adverse Events

Fastrach

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mogens Ydemann

Department of Anaesthesiology, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark

Phone: +4531155995

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place