Trial Outcomes & Findings for Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy (NCT NCT02775214)

Last Updated: 2023-11-01

Results Overview

Patient had a desaturation below 80% during intubation with either conventional laryngoscope or video laryngoscope

Recruitment status

TERMINATED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

During intubation attempt (less than two minutes)

Results posted on

2023-11-01

4/19/17-7/12/22 pediatric hospital infants \<6m with pyloric stenosis

Participant milestones
Measure	Conventional Direct Laryngoscopy Endotracheal intubation will be performed by conventional direct laryngoscopy.	Video Laryngoscopy Endotracheal intubation will be performed by video laryngoscopy with the C-MAC. Video Laryngoscopy
Overall Study STARTED	30	32
Overall Study COMPLETED	28	32
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal
Measure	Conventional Direct Laryngoscopy Endotracheal intubation will be performed by conventional direct laryngoscopy.	Video Laryngoscopy Endotracheal intubation will be performed by video laryngoscopy with the C-MAC. Video Laryngoscopy
Overall Study Withdrawal by Subject	2	0

Sex/Gender were not collected from any participant.

Baseline characteristics by cohort
Measure	Conventional Direct Laryngoscopy n=30 Participants Endotracheal intubation will be performed by conventional direct laryngoscopy.	Video Laryngoscopy n=32 Participants Endotracheal intubation will be performed by video laryngoscopy with the C-MAC. Video Laryngoscopy	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=30 Participants	32 Participants n=32 Participants	62 Participants n=62 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=30 Participants	0 Participants n=32 Participants	0 Participants n=62 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	0 Participants n=32 Participants	0 Participants n=62 Participants
Sex: Female, Male Female	—	—	0 Participants Sex/Gender were not collected from any participant.
Sex: Female, Male Male	—	—	0 Participants Sex/Gender were not collected from any participant.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Pyloric Stenosis	30 Participants n=30 Participants	32 Participants n=32 Participants	62 Participants n=62 Participants

Timeframe: During intubation attempt (less than two minutes)

Patient had a desaturation below 80% during intubation with either conventional laryngoscope or video laryngoscope

Outcome measures
Measure	Conventional Direct Laryngoscopy n=30 Participants Endotracheal intubation will be performed by conventional direct laryngoscopy.	Video Laryngoscopy n=32 Participants Endotracheal intubation will be performed by video laryngoscopy with the C-MAC.
Number of Participants Who Had Desaturation Below 80% During Intubation	6 Participants	4 Participants

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Conventional Direct Laryngoscopy n=30 participants at risk Endotracheal intubation will be performed by conventional direct laryngoscopy.	Video Laryngoscopy n=32 participants at risk Endotracheal intubation will be performed by video laryngoscopy with the C-MAC.
Respiratory, thoracic and mediastinal disorders desaturation	20.0% 6/30 • Number of events 6 • Adverse event data was collected per patient from intubation through recovery period, a time frame of 24 hours Adverse event was defined as desaturation below 80% during intubation	12.5% 4/32 • Number of events 4 • Adverse event data was collected per patient from intubation through recovery period, a time frame of 24 hours Adverse event was defined as desaturation below 80% during intubation

Adverse event data not reported

Riley Hospital for Children at Indiana University Health

Phone: 3179449981