Trial Outcomes & Findings for VL vs DL in Inexperienced Users: a Pediatric Manikin Study (NCT NCT02991820)

Results Overview

The amount of time it took to successfully intubate the manikin using each device.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

43 participants

Primary outcome timeframe

the same day (within seconds to minutes)

Results posted on

2018-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Inexperienced Users Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH. Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).	Experienced Users Experienced users will include faculty pediatric anesthesiologists CRNAs. Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).
Overall Study STARTED	12	31
Overall Study COMPLETED	12	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inexperienced Users n=12 Participants Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH. Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).	Experienced Users n=31 Participants Experienced users will include faculty pediatric anesthesiologists CRNAs. Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=31 Participants	0 Participants n=43 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants	31 Participants n=31 Participants	43 Participants n=43 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants	0 Participants n=31 Participants	0 Participants n=43 Participants
Sex: Female, Male Female	NA Participants n=12 Participants	NA Participants n=31 Participants	NA Participants n=43 Participants
Sex: Female, Male Male	NA Participants n=12 Participants	NA Participants n=31 Participants	NA Participants n=43 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	31 participants n=31 Participants	43 participants n=43 Participants

PRIMARY outcome

Timeframe: the same day (within seconds to minutes)

The amount of time it took to successfully intubate the manikin using each device.

Outcome measures

Outcome measures
Measure	Inexperienced Users n=12 Participants Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH. Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).	Experienced Users n=31 Participants Experienced users will include faculty pediatric anesthesiologists CRNAs. Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).
Time to Endotracheal Intubation C-Mac	61 seconds Standard Deviation 34	20 seconds Standard Deviation 13
Time to Endotracheal Intubation Miller	72 seconds Standard Deviation 45	30 seconds Standard Deviation 28
Time to Endotracheal Intubation Macintosh	72 seconds Standard Deviation 45	27 seconds Standard Deviation 23
Time to Endotracheal Intubation GlideScope	118 seconds Standard Deviation 6	85 seconds Standard Deviation 38

SECONDARY outcome

Timeframe: 2 minutes

The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.

Outcome measures

Outcome measures
Measure	Inexperienced Users n=12 Participants Inexperienced users will include trainees (SRNAs, residents, fellows, and medical students) and nurses at NCH. Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).	Experienced Users n=31 Participants Experienced users will include faculty pediatric anesthesiologists CRNAs. Intubation: Each participant will perform endotracheal intubation on the mannequin using videolaryngoscopes (VL) and traditional direct laryngoscopy (DL).
Successful Intubation Within 120 Seconds Miller	7 Participants	30 Participants
Successful Intubation Within 120 Seconds Macintosh	7 Participants	31 Participants
Successful Intubation Within 120 Seconds C-Mac	11 Participants	31 Participants
Successful Intubation Within 120 Seconds GlideScope	2 Participants	20 Participants

Adverse Events

Inexperienced Users

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experienced Users

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

Joseph D. Tobias, MD

Nationwide Children's Hospital

Phone: 6147224200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place