Trial Outcomes & Findings for Tracheal Intubation Coaching in NICUs (NCT NCT03194503)

NCT ID: NCT03194503

Last Updated: 2021-04-09

Results Overview

Reduction in the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years after neonatology attendings receive video coaching skill training.

Recruitment status

COMPLETED

Study phase

Target enrollment

1512 participants

Primary outcome timeframe

2 years

Results posted on

2021-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Pre-Intervention Intubations before VL coaching using train-the-trainer mechanism was implemented.	Post- Intervention Intubations after VL coaching using train-the-trainer mechanism was implemented.
Overall Study STARTED	458	1054
Overall Study COMPLETED	458	1054
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tracheal Intubation Coaching in NICUs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-Intervention n=458 Participants Intubations before VL coaching using train-the-trainer mechanism was implemented.	Post-Intervention n=1054 Participants Intubations after VL coaching using train-the-trainer mechanism was implemented.	Total n=1512 Participants Total of all reporting groups
Age, Categorical <=18 years	458 Participants n=5 Participants	1054 Participants n=7 Participants	1512 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	196 Participants n=5 Participants	452 Participants n=7 Participants	648 Participants n=5 Participants
Sex: Female, Male Male	262 Participants n=5 Participants	602 Participants n=7 Participants	864 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Asian	24 Participants n=5 Participants	53 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	70 Participants n=5 Participants	161 Participants n=7 Participants	231 Participants n=5 Participants
Race (NIH/OMB) White	329 Participants n=5 Participants	759 Participants n=7 Participants	1088 Participants n=5 Participants
Race (NIH/OMB) More than one race	27 Participants n=5 Participants	63 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: The primary outcome is comparing the number of participants with intubations before the intervention implementation phase (n=458) and the number of participants with intubations in the post intervention implementation phase (n=1,054), total n=1,512 for outcome 1.

Outcome measures

Outcome measures
Measure	Pre-Intervention n=458 Participants Intubations before VL coaching using train-the-trainer mechanism was implemented.	Post-Intervention n=1054 Participants Intubations after VL coaching using train-the-trainer mechanism was implemented.
Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years Severe Desaturation (>20%)	244 Participants	491 Participants
Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years Any TIAEs	138 Participants	214 Participants
Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years Severe TIAEs	33 Participants	51 Participants

SECONDARY outcome

Timeframe: 18 months

Population: The number of participants in this outcome measure include those intubated with VL coaching (n=155) and those intubated without VL coaching (n=984), total n=1,139 for outcome measure 2.

Intubations with VL coaching vs. no VL coaching (incl: DL\&VL) can reduce severe oxygen desaturation: Oxygen desaturation defined as highest -lowest SpO2 during the intubation is \>20% (absolute value). Intervention timing was randomized based on the site size.

Outcome measures

Outcome measures
Measure	Pre-Intervention n=155 Participants Intubations before VL coaching using train-the-trainer mechanism was implemented.	Post-Intervention n=984 Participants Intubations after VL coaching using train-the-trainer mechanism was implemented.
Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching Any TIAEs	23 Participants	209 Participants
Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching Severe TIAEs	5 Participants	49 Participants
Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching Severe Desaturation (>20%)	99 Participants	438 Participants

Adverse Events

Pre-Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post-Intervention

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

Dr. Akira Nishisaki

The Children's Hospital of Philadelphia

Phone: 267-426-0665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place