Trial Outcomes & Findings for Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope (NCT NCT01683526)

NCT ID: NCT01683526

Last Updated: 2014-10-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 117 participants
• Primary outcome timeframe: From begining of intubation to verification. Less then 5 minutes approximatly
• Results posted on: 2014-10-20

Participant Flow

Participant milestones

Measure	Direct Laryngoscopy Intubation will be done using direct laryngoscopy Direct laryngoscopy	Video Laryngoscopy Intubation will be done using video laryngoscopy Video laryngoscopy (Glidescope)
Overall Study STARTED	60	57
Overall Study COMPLETED	60	57
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope

Baseline characteristics by cohort

Measure	Direct Laryngoscopy n=60 Participants Intubation will be done using direct laryngoscopy Direct laryngoscopy	Video Laryngoscopy n=57 Participants Intubation will be done using video laryngoscopy Video laryngoscopy (Glidescope)	Total n=117 Participants Total of all reporting groups
Age, Continuous	69.6 years STANDARD_DEVIATION 15.9 • n=5 Participants	65.4 years STANDARD_DEVIATION 14.0 • n=7 Participants	67.4 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	27 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: From begining of intubation to verification. Less then 5 minutes approximatly

Outcome measures

Measure	Direct Laryngoscopy n=60 Participants Intubation will be done using direct laryngoscopy Direct laryngoscopy	Video Laryngoscopy n=57 Participants Intubation will be done using video laryngoscopy Video laryngoscopy (Glidescope)
First Pass Success Rate	24 percentage of first pass success	42 percentage of first pass success

SECONDARY outcome

Timeframe: For 10 minutes post intubation

sat <80%

Outcome measures

Measure	Direct Laryngoscopy n=60 Participants Intubation will be done using direct laryngoscopy Direct laryngoscopy	Video Laryngoscopy n=57 Participants Intubation will be done using video laryngoscopy Video laryngoscopy (Glidescope)
Severe Desaturation	5 percentage of patients with desaturation	2 percentage of patients with desaturation

SECONDARY outcome

Timeframe: For 10 minutes post intubation

SBP<70

Outcome measures

Measure	Direct Laryngoscopy n=60 Participants Intubation will be done using direct laryngoscopy Direct laryngoscopy	Video Laryngoscopy n=57 Participants Intubation will be done using video laryngoscopy Video laryngoscopy (Glidescope)
Hypotension	8 percentage of hypotension	6 percentage of hypotension

SECONDARY outcome

Timeframe: For 1 hour post intubation

Outcome measures

Measure	Direct Laryngoscopy n=60 Participants Intubation will be done using direct laryngoscopy Direct laryngoscopy	Video Laryngoscopy n=57 Participants Intubation will be done using video laryngoscopy Video laryngoscopy (Glidescope)
Cardiac Arrest	0 percentage of cardiac arrest	1 percentage of cardiac arrest

SECONDARY outcome

Timeframe: For 10 minutes post intubation

Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.

Outcome measures

Measure	Direct Laryngoscopy n=60 Participants Intubation will be done using direct laryngoscopy Direct laryngoscopy	Video Laryngoscopy n=57 Participants Intubation will be done using video laryngoscopy Video laryngoscopy (Glidescope)
Complications of Intubation	9 percentage of other complications	6 percentage of other complications

Adverse Events

Direct Laryngoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Michael Silverberg

Beth Israel Medical center

Phone: 2124202377

Email: msilverberg2@chpnet.org

Results disclosure agreements

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