Trial Outcomes & Findings for STorz Against Glidescope Effectiveness (NCT NCT01632683)

Results Overview

Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1100 participants

Primary outcome timeframe

1 week

Results posted on

2017-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	C-MAC Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm	Glidescope Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm
Overall Study STARTED	548	552
Overall Study COMPLETED	548	552
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

STorz Against Glidescope Effectiveness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C-MAC n=548 Participants Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm	Glidescope n=552 Participants Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm	Total n=1100 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 13.7 • n=5 Participants	54.4 years STANDARD_DEVIATION 14.1 • n=7 Participants	53.7 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	292 Participants n=5 Participants	267 Participants n=7 Participants	559 Participants n=5 Participants
Sex: Female, Male Male	256 Participants n=5 Participants	285 Participants n=7 Participants	541 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide

Outcome measures

Outcome measures
Measure	C-MAC n=548 Participants Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm	Glidescope n=552 Participants Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm
Intubation Success Rate	512 participants	531 participants

SECONDARY outcome

Timeframe: 1 week

Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide

Outcome measures

Outcome measures
Measure	C-MAC n=548 Participants Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm	Glidescope n=552 Participants Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm
Intubation Time	47 seconds Interval 39.0 to 60.0	47 seconds Interval 38.0 to 58.0

SECONDARY outcome

Timeframe: 1 week

Population: Cormack-Lehane grade

Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team. Grade 1 is considered to be a good view while grade 4 is considered to be a poor view.

Outcome measures

Outcome measures
Measure	C-MAC n=4 grade Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm	Glidescope n=4 grade Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm
Graded Score of Laryngeal View Achieved Grade 1	482 participants	398 participants
Graded Score of Laryngeal View Achieved Grade 2	41 participants	146 participants
Graded Score of Laryngeal View Achieved Grade 3	8 participants	11 participants
Graded Score of Laryngeal View Achieved Grade 4	10 participants	2 participants

SECONDARY outcome

Timeframe: 1 week

The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team.

Outcome measures

Outcome measures
Measure	C-MAC n=548 Participants Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm	Glidescope n=552 Participants Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm
Number of Particpants Requiring Adjuncts to Assist Intubation	117 Participants	128 Participants

SECONDARY outcome

Timeframe: 1 week

Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling.

Outcome measures

Outcome measures
Measure	C-MAC n=548 Participants Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm	Glidescope n=552 Participants Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm
Number of Participants With Observed Complications	97 Participants	85 Participants

Adverse Events

C-MAC

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Glidescope

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	C-MAC n=548 participants at risk Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm	Glidescope n=552 participants at risk Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm
Surgical and medical procedures pharyngeal injury	0.73% 4/548	1.3% 7/552

Additional Information

Michael Aziz, MD

Oregon Health & Science University

Phone: 503-494-5581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place