Trial Outcomes & Findings for Chest Compression and Sustained Inflation (NCT NCT02083705)
NCT ID: NCT02083705
Last Updated: 2025-03-30
Results Overview
We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
within the first 10 minutes after birth
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
SI+CC
Chest compression will be superimposed by sustained inflations during CPR:
"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.
CC+SI: Chest compression will be superimposed by sustained inflation during CPR
|
3:1 CPR
CPR using 3:1 C:V ratio:
"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.
3:1 CPR: CPR using 3:1 ratio (control group)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chest Compression and Sustained Inflation
Baseline characteristics by cohort
| Measure |
SI+CC
n=5 Participants
Chest compression will be superimposed by sustained inflations during CPR:
"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.
CC+SI: Chest compression will be superimposed by sustained inflation during CPR
|
3:1 CPR
n=4 Participants
CPR using 3:1 C:V ratio:
"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.
3:1 CPR: CPR using 3:1 ratio (control group)
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: within the first 10 minutes after birthWe aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique
Outcome measures
| Measure |
SI+CC
n=5 Participants
Chest compression will be superimposed by sustained inflations during CPR:
"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.
CC+SI: Chest compression will be superimposed by sustained inflation during CPR
|
3:1 CPR
n=4 Participants
CPR using 3:1 C:V ratio:
"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.
3:1 CPR: CPR using 3:1 ratio (control group)
|
|---|---|---|
|
Time Needed to Achieve Return of Spontaneous Circulation
|
31 seconds
Standard Deviation 9
|
138 seconds
Standard Deviation 72
|
Adverse Events
SI+CC
Serious events: 1 serious events
Other events: 0 other events
Deaths: 2 deaths
3:1 CPR
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SI+CC
n=5 participants at risk
Chest compression will be superimposed by sustained inflations during CPR:
"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.
CC+SI: Chest compression will be superimposed by sustained inflation during CPR
|
3:1 CPR
n=4 participants at risk
CPR using 3:1 C:V ratio:
"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.
3:1 CPR: CPR using 3:1 ratio (control group)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Air leak
|
0.00%
0/5 • within 6 months
|
0.00%
0/4 • within 6 months
|
|
Nervous system disorders
Intraventricular haemorrhage all grades
|
20.0%
1/5 • Number of events 1 • within 6 months
|
100.0%
4/4 • Number of events 4 • within 6 months
|
|
Nervous system disorders
Intraventricular haemorrhage grade >3
|
20.0%
1/5 • Number of events 1 • within 6 months
|
50.0%
2/4 • Number of events 2 • within 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place