Trial Outcomes & Findings for Manikin To Patient Intubation: Does It Translate? (NCT NCT03046966)
NCT ID: NCT03046966
Last Updated: 2021-07-07
Results Overview
Residents reported the number of successful intubation encounters they performed during their one month long NICU rotation. A successful intubation encounter is an intubation procedure where the resident successfully placed the the endotracheal tube (ETT) through the vocal cords into the trachea. Placement was confirmed with xray, chest auscultation, improvement in heart rate, and CO2 detectors.
COMPLETED
NA
102 participants
1 month- neonatal intensive care unit (NICU) rotation
2021-07-07
Participant Flow
102 residents were approached for enrollment. 102 residents were consented and randomized to intervention or control based on month of NICU rotation.
Participant milestones
| Measure |
Intervention Control: No Training
Does not receive hands-on intubation training in the Simulation Lab.
Intervention: Control No Training: • Does not receive simulation training with PI. Only standard training.
|
Intervention: Receives Training
Receives hands-on intubation training in the Simulation Lab.
Intervention: Receives Training: • Complete a Hands-on Intubation in the Simulation Lab with PI instructing:
* Using state of the art technology, a Storz C-MAC video laryngoscope
* Identifying anatomical landmarks
* Practice on the manikin until intubation occurs within 15 seconds
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Manikin To Patient Intubation: Does It Translate?
Baseline characteristics by cohort
| Measure |
Control Group
n=51 Participants
Control: No Training Residents received standard training consisting of intern orientation.
|
Intervention Group
n=51 Participants
Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=39 Participants
|
51 Participants
n=41 Participants
|
102 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
67 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=39 Participants
|
48 Participants
n=41 Participants
|
96 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=39 Participants
|
51 Participants
n=41 Participants
|
102 Participants
n=35 Participants
|
|
Level of Training (year)
First year
|
30 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
66 Participants
n=35 Participants
|
|
Level of Training (year)
Second year
|
14 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Level of Training (year)
Third year
|
7 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Level of Training (year)
Fourth Year
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Comfort with Intubation
Not very comfortable
|
22 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
|
Comfort with Intubation
Somewhat comfortable
|
12 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Comfort with Intubation
Neutral
|
9 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Comfort with Intubation
Comfortable
|
8 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Comfort with Intubation
Very comfortable
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Baseline Successful Intubation Rate
0-25%
|
9 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Baseline Successful Intubation Rate
25-50%
|
6 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Baseline Successful Intubation Rate
50-75%
|
12 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Baseline Successful Intubation Rate
75-100%
|
6 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Baseline Successful Intubation Rate
Not Applicable
|
18 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 1 month- neonatal intensive care unit (NICU) rotationResidents reported the number of successful intubation encounters they performed during their one month long NICU rotation. A successful intubation encounter is an intubation procedure where the resident successfully placed the the endotracheal tube (ETT) through the vocal cords into the trachea. Placement was confirmed with xray, chest auscultation, improvement in heart rate, and CO2 detectors.
Outcome measures
| Measure |
Control Group
n=93 Intubation Encounters
Control: No Training Residents received standard training consisting of intern orientation.
|
Intervention Group
n=119 Intubation Encounters
Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.
|
|---|---|---|
|
Successful Intubation Encounters on Live Neonates
|
1.02 Successful Intubation Encounters
Standard Error 0.167
|
1.18 Successful Intubation Encounters
Standard Error 0.183
|
SECONDARY outcome
Timeframe: 1 month- NICU rotationPopulation: Six residents in the Control group did not report the number of successful intubation encounters completed with only one attempt.
Each resident reported the number of successful intubation encounters requiring one attempt on live infants during their NICU rotation. An intubation attempt occurs any time the laryngoscope enters the neonate's mouth. There can be multiple intubation attempts in one intubation encounter. However this outcome focuses on intubation encounters where the neonate was intubated on the first attempt by the resident.
Outcome measures
| Measure |
Control Group
n=45 Participants
Control: No Training Residents received standard training consisting of intern orientation.
|
Intervention Group
n=51 Participants
Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.
|
|---|---|---|
|
Successful Intubations on the First Attempt
|
0.578 Successful First Attempt Intubations
Standard Error 0.133
|
0.840 Successful First Attempt Intubations
Standard Error 0.161
|
SECONDARY outcome
Timeframe: 1 month- NICU rotationThe mean number of intubation encounters performed by each resident during their NICU rotation was compared between the Control and Intervention groups.
Outcome measures
| Measure |
Control Group
n=51 Participants
Control: No Training Residents received standard training consisting of intern orientation.
|
Intervention Group
n=51 Participants
Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.
|
|---|---|---|
|
Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation
|
1.82 Intubation Encounters
Standard Error 0.189
|
2.33 Intubation Encounters
Standard Error 0.214
|
SECONDARY outcome
Timeframe: 1 month- NICU rotationAll study residents intubated the mannequin before and after their NICU rotation. The total time of the mannequin intubation encounter was recorded. The difference in the time from end of the NICU rotation and the baseline time (beginning of the NICU rotation) was calculated.
Outcome measures
| Measure |
Control Group
n=51 Participants
Control: No Training Residents received standard training consisting of intern orientation.
|
Intervention Group
n=51 Participants
Intervention Group: Received individualized with a neonatologist at the beginning of the NICU rotation utilizing video laryngoscope and a neonatal mannequin. These residents also received standard training at intern orientation.
|
|---|---|---|
|
Change in Time to Intubate the Mannequin
|
18.6 Seconds
Standard Error 9.61
|
37.6 Seconds
Standard Error 8.7
|
Adverse Events
Intervention Control: No Training
Intervention: Receives Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Rumpel, MD
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place