Trial Outcomes & Findings for The Use of the GlideScope Ranger in Pediatric Critical Care Transport (NCT NCT01054183)

NCT ID: NCT01054183

Last Updated: 2015-02-23

Results Overview

Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2015-02-23

Participant Flow

Prospectively enrolled 22 patients between 8/1/2010 - 5/1/2012.

Prior to the initiation of the study, staff received didactic and simulation based instruction with the Glidescope Video Laryngoscope (GVL) and demonstrated competency through a minimum of 5 successful intubations in patients >10 kg and 1 intubation in a patient < or = 10 Kg in a controlled operating room setting.

Participant milestones

Measure	GlideScope Ranger Intubation The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day. GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope	Direct Laryngoscopy Intubation The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day. Direct Laryngoscopy : Intubations will be done with direct laryngoscopy.
Overall Study STARTED	10	12
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of the GlideScope Ranger in Pediatric Critical Care Transport

Baseline characteristics by cohort

Measure	GlideScope Ranger Intubation n=10 Participants The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day. GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope	Direct Laryngoscopy Intubation n=12 Participants The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day. Direct Laryngoscopy : Intubations will be done with direct laryngoscopy.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	2.1 years STANDARD_DEVIATION 4.56 • n=5 Participants	1.5 years STANDARD_DEVIATION 3.02 • n=7 Participants	1.8 years STANDARD_DEVIATION 3.71 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)

Outcome measures

Measure	GlideScope Ranger Intubation n=10 Participants The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day. GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope	Direct Laryngoscopy Intubation n=12 Participants The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day. Direct Laryngoscopy : Intubations will be done with direct laryngoscopy.
Percent of Participants With Successful 1st Intubation Attempt	30 Percent of Participants	41.67 Percent of Participants

PRIMARY outcome

Timeframe: 30 days; no long-term outcome measures were included

Population: The study was powered for 62 patients per study arm. Due to slow patient enrollment, the study was stopped prior to full enrollment with the aforementioned 22 total patients.

Overall successful intubation rate defined as all successful intubations (by type) divided by all attempts (by type).

Outcome measures

Measure	GlideScope Ranger Intubation n=19 total intubation attempts The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day. GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope	Direct Laryngoscopy Intubation n=28 total intubation attempts The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day. Direct Laryngoscopy : Intubations will be done with direct laryngoscopy.
Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL).	26.3 Percent of successful intubations	64.3 Percent of successful intubations

Adverse Events

GlideScope Video Laryngoscope Ranger(GVL)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Direct Laryngoscopy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	GlideScope Video Laryngoscope Ranger(GVL) n=10 participants at risk Procedure used to perform tracheal intubation that facilitates indirect visualization of the glottis through a video display.	Direct Laryngoscopy n=12 participants at risk Procedure used to visualize the vocal cords and perform tracheal intubation in the pediatric and neonatal population.
Respiratory, thoracic and mediastinal disorders Secretions	20.0% 2/10 • Number of events 2 • 30 days	33.3% 4/12 • Number of events 4 • 30 days
Respiratory, thoracic and mediastinal disorders Insufficient view	20.0% 2/10 • Number of events 2 • 30 days	8.3% 1/12 • Number of events 1 • 30 days
Respiratory, thoracic and mediastinal disorders Hypoxemia	60.0% 6/10 • Number of events 6 • 30 days	8.3% 1/12 • Number of events 1 • 30 days
Respiratory, thoracic and mediastinal disorders Difficult passing ETT with stylet	50.0% 5/10 • Number of events 5 • 30 days	8.3% 1/12 • Number of events 1 • 30 days
Nervous system disorders Patient movement	30.0% 3/10 • Number of events 3 • 30 days	0.00% 0/12 • 30 days
Cardiac disorders Bradycardia	10.0% 1/10 • Number of events 1 • 30 days	0.00% 0/12 • 30 days
Respiratory, thoracic and mediastinal disorders Wrong size blade	20.0% 2/10 • Number of events 2 • 30 days	0.00% 0/12 • 30 days
Respiratory, thoracic and mediastinal disorders Tube size inappropriate	0.00% 0/10 • 30 days	16.7% 2/12 • Number of events 2 • 30 days

Additional Information

Michael T. Bigham, MD

Akron Children's Hospital

Phone: 330-543-8639

Email: MBigham@chmca.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place