Trial Outcomes & Findings for Hemodynamic Effects of Standard Cardiopulmonary Resuscitation (CPR), Active Compression Decompression CPR With an Inspiratory Impedance Device, and Standard CPR With an Intrathoracic Pressure Regulator During Out-of-hospital Cardiac Arrest (NCT NCT01325870)
NCT ID: NCT01325870
Last Updated: 2016-08-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
during CPR (day 1)
Results posted on
2016-08-12
Participant Flow
Participant milestones
| Measure |
ACD-CPR +ITD
ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
|
S-CPR + ITPR
S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
|
S-CPR
S-CPR: standard manual CPR
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
14
|
|
Overall Study
COMPLETED
|
7
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hemodynamic Effects of Standard Cardiopulmonary Resuscitation (CPR), Active Compression Decompression CPR With an Inspiratory Impedance Device, and Standard CPR With an Intrathoracic Pressure Regulator During Out-of-hospital Cardiac Arrest
Baseline characteristics by cohort
| Measure |
ACD-CPR +ITD
n=18 Participants
ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
|
S-CPR + ITPR
n=16 Participants
S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
|
S-CPR
n=14 Participants
S-CPR: standard manual CPR
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 18.9 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 15.8 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
14 participants
n=5 Participants
|
48 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: during CPR (day 1)Outcome measures
| Measure |
ACD-CPR +ITD
n=7 Participants
ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
|
S-CPR + ITPR
n=3 Participants
S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
|
S-CPR
n=6 Participants
S-CPR: standard manual CPR
|
|---|---|---|---|
|
Mean Systolic and Diastolic Blood Pressures
Systolic
|
80.38 mmHg
Standard Deviation 20.71
|
121.21 mmHg
Standard Deviation 22.13
|
61.37 mmHg
Standard Deviation 26.23
|
|
Mean Systolic and Diastolic Blood Pressures
Diastolic
|
15.52 mmHg
Standard Deviation 14.10
|
33.04 mmHg
Standard Deviation 24.69
|
19.29 mmHg
Standard Deviation 17.31
|
PRIMARY outcome
Timeframe: during the index CPR procedure (day 1), at hospital discharge, at 30 days, at three months, and at six months of follow-upSerious adverse events include: death, internal thoracic and abdominal injuries, device malfunction preventing use during CPR
Outcome measures
| Measure |
ACD-CPR +ITD
n=18 Participants
ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
|
S-CPR + ITPR
n=16 Participants
S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
|
S-CPR
n=14 Participants
S-CPR: standard manual CPR
|
|---|---|---|---|
|
Serious Adverse Events
|
11 events
|
9 events
|
8 events
|
SECONDARY outcome
Timeframe: during CPR (day 1)Intrathoracic pressures are reported relative to atmospheric pressure
Outcome measures
| Measure |
ACD-CPR +ITD
n=7 Participants
ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
|
S-CPR + ITPR
n=3 Participants
S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
|
S-CPR
n=6 Participants
S-CPR: standard manual CPR
|
|---|---|---|---|
|
Mean Intrathoracic Pressure (Airway Pressure)
|
-1.05 mmHg
Standard Deviation 2.40
|
-4.40 mmHg
Standard Deviation 3.25
|
1.21 mmHg
Standard Deviation 2.57
|
Adverse Events
ACD-CPR +ITD
Serious events: 10 serious events
Other events: 1 other events
Deaths: 0 deaths
S-CPR + ITPR
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
S-CPR
Serious events: 6 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACD-CPR +ITD
n=18 participants at risk
ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
|
S-CPR + ITPR
n=16 participants at risk
S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
|
S-CPR
n=14 participants at risk
S-CPR: standard manual CPR
|
|---|---|---|---|
|
Nervous system disorders
Death
|
55.6%
10/18
|
50.0%
8/16
|
42.9%
6/14
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
5.6%
1/18
|
6.2%
1/16
|
7.1%
1/14
|
|
Investigations
Device failure
|
5.6%
1/18
|
12.5%
2/16
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Blood in advanced airway
|
5.6%
1/18
|
6.2%
1/16
|
7.1%
1/14
|
|
Cardiac disorders
Re-arrest
|
11.1%
2/18
|
18.8%
3/16
|
0.00%
0/14
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18
|
6.2%
1/16
|
0.00%
0/14
|
Other adverse events
| Measure |
ACD-CPR +ITD
n=18 participants at risk
ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
|
S-CPR + ITPR
n=16 participants at risk
S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
|
S-CPR
n=14 participants at risk
S-CPR: standard manual CPR
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Blood in advanced airway
|
5.6%
1/18
|
0.00%
0/16
|
7.1%
1/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60