Trial Outcomes & Findings for Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients (NCT NCT01023568)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

134 participants

Primary outcome timeframe

from start of intubation to successfully intubated up to 5 minutes

Results posted on

2017-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	Macintosh Blade Intubation with Macintosh blade laryngoscope Macintosh blade: Intubation with Macintosh blade laryngoscope	Glidescope Intubation with Glidescope laryngoscope Glidescope: Intubation with Glidescope laryngoscope.	Truview PCD Intubation with the Truview PCD laryngoscope Truview PCD: Intubation with Truview PCD laryngoscope.
Overall Study STARTED	45	44	45
Overall Study COMPLETED	45	44	45
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Direct Laryngoscopy, Truview EVO2 and Glidescope in Pediatric Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Macintosh Blade n=45 Participants Intubation with Macintosh blade laryngoscope Macintosh blade: Intubation with Macintosh blade laryngoscope	Glidescope n=44 Participants Intubation with Glidescope laryngoscope Glidescope: Intubation with Glidescope laryngoscope.	Truview PCD n=45 Participants Intubation with the Truview PCD laryngoscope Truview PCD: Intubation with Truview PCD laryngoscope.	Total n=134 Participants Total of all reporting groups
Age, Continuous	4.0 years STANDARD_DEVIATION 2.8 • n=5 Participants	4.6 years STANDARD_DEVIATION 2.7 • n=7 Participants	5.2 years STANDARD_DEVIATION 2.8 • n=5 Participants	4.6 years STANDARD_DEVIATION 2.8 • n=4 Participants
Gender Female	16 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	41 Participants n=4 Participants
Gender Male	29 Participants n=5 Participants	33 Participants n=7 Participants	31 Participants n=5 Participants	93 Participants n=4 Participants
Body mass index	17 kg/m2 n=5 Participants	16 kg/m2 n=7 Participants	16 kg/m2 n=5 Participants	16.5 kg/m2 n=4 Participants
ASA physical status I: A normal healthy patient	19 participants n=5 Participants	20 participants n=7 Participants	19 participants n=5 Participants	58 participants n=4 Participants
ASA physical status II: A patient with mild systemic disease	24 participants n=5 Participants	23 participants n=7 Participants	25 participants n=5 Participants	72 participants n=4 Participants
ASA physical status III: A patient with severe systemic disease	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants

PRIMARY outcome

Timeframe: from start of intubation to successfully intubated up to 5 minutes

Outcome measures

Outcome measures
Measure	Macintosh Blade n=45 Participants Intubation with Macintosh blade laryngoscope Macintosh blade: Intubation with Macintosh blade laryngoscope	Glidescope n=44 Participants Intubation with Glidescope laryngoscope Glidescope: Intubation with Glidescope laryngoscope.	Truview PCD n=45 Participants Intubation with the Truview PCD laryngoscope Truview PCD: Intubation with Truview PCD laryngoscope.
Time to Successfully Intubate Patient.	23 seconds Interval 21.0 to 28.0	39 seconds Interval 31.0 to 59.0	44 seconds Interval 28.0 to 62.0

SECONDARY outcome

Timeframe: measured at 1 minute interval at induction time and from intubation for 10 minutes

Outcome measures

Outcome measures
Measure	Macintosh Blade n=45 Participants Intubation with Macintosh blade laryngoscope Macintosh blade: Intubation with Macintosh blade laryngoscope	Glidescope n=44 Participants Intubation with Glidescope laryngoscope Glidescope: Intubation with Glidescope laryngoscope.	Truview PCD n=45 Participants Intubation with the Truview PCD laryngoscope Truview PCD: Intubation with Truview PCD laryngoscope.
Mean Hemodynamic Response: Mean Arterial Blood Pressure	62 mmHg Standard Deviation 12	63 mmHg Standard Deviation 9	66 mmHg Standard Deviation 12

SECONDARY outcome

Timeframe: immediately after intubation

Outcome measures

Outcome measures
Measure	Macintosh Blade n=45 Participants Intubation with Macintosh blade laryngoscope Macintosh blade: Intubation with Macintosh blade laryngoscope	Glidescope n=44 Participants Intubation with Glidescope laryngoscope Glidescope: Intubation with Glidescope laryngoscope.	Truview PCD n=45 Participants Intubation with the Truview PCD laryngoscope Truview PCD: Intubation with Truview PCD laryngoscope.
Cormack-Lehane Grade 1: Full view of glottis	34 participants	6 participants	37 participants
Cormack-Lehane Grade 2: Partial view of glottis	6 participants	13 participants	7 participants
Cormack-Lehane Grade 3: Only epiglottis seen, none of glottis seen	5 participants	23 participants	1 participants
Cormack-Lehane Grade 4: Neither glottis nor epiglottis seen	0 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: measured at 1 minute interval at induction time and from intubation for 10 minutes.

Outcome measures

Outcome measures
Measure	Macintosh Blade n=45 Participants Intubation with Macintosh blade laryngoscope Macintosh blade: Intubation with Macintosh blade laryngoscope	Glidescope n=44 Participants Intubation with Glidescope laryngoscope Glidescope: Intubation with Glidescope laryngoscope.	Truview PCD n=45 Participants Intubation with the Truview PCD laryngoscope Truview PCD: Intubation with Truview PCD laryngoscope.
Mean Hemodynamic Response: Heart Rate	126 beats/min Standard Deviation 21	127 beats/min Standard Deviation 15	128 beats/min Standard Deviation 18

SECONDARY outcome

Timeframe: measured at 1 minute interval at induction time and from intubation for 10 minutes.

Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after

Outcome measures

Outcome measures
Measure	Macintosh Blade n=45 Participants Intubation with Macintosh blade laryngoscope Macintosh blade: Intubation with Macintosh blade laryngoscope	Glidescope n=44 Participants Intubation with Glidescope laryngoscope Glidescope: Intubation with Glidescope laryngoscope.	Truview PCD n=45 Participants Intubation with the Truview PCD laryngoscope Truview PCD: Intubation with Truview PCD laryngoscope.
Number of Participants Who Experienced Desaturation	1 participants	0 participants	1 participants

Adverse Events

Macintosh Blade

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

Truview PCD

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

Roberta Johnson

Cleveland Clinic

Phone: 216-444-9950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place