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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

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ClinicalTrials.gov Identifier: NCT01325870
Recruitment Status : Completed
First Posted : March 30, 2011
Results First Posted : July 17, 2014
Last Update Posted : August 12, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Advanced Circulatory Systems

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cardiac Arrest
Sudden Cardiac Death
Interventions Device: ACD-CPR
Device: ITPR
Procedure: S-CPR
Device: Impedance Threshold Device (ITD)
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACD-CPR +ITD S-CPR + ITPR S-CPR
Hide Arm/Group Description 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: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR) S-CPR: standard manual CPR
Period Title: Overall Study
Started 18 16 14
Completed 7 3 6
Not Completed 11 13 8
Arm/Group Title ACD-CPR +ITD S-CPR + ITPR S-CPR Total
Hide Arm/Group Description 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: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR) S-CPR: standard manual CPR Total of all reporting groups
Overall Number of Baseline Participants 18 16 14 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 14 participants 48 participants
63.1  (14.6) 66.8  (18.9) 64.7  (14.0) 64.8  (15.8)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 14 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  55.6%
5
  31.3%
7
  50.0%
22
  45.8%
>=65 years
8
  44.4%
11
  68.8%
7
  50.0%
26
  54.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 14 participants 48 participants
Female
10
  55.6%
7
  43.8%
5
  35.7%
22
  45.8%
Male
8
  44.4%
9
  56.3%
9
  64.3%
26
  54.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 16 participants 14 participants 48 participants
18 16 14 48
1.Primary Outcome
Title Mean Systolic and Diastolic Blood Pressures
Hide Description [Not Specified]
Time Frame during CPR (day 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACD-CPR +ITD S-CPR + ITPR S-CPR
Hide Arm/Group Description:
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: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
S-CPR: standard manual CPR
Overall Number of Participants Analyzed 7 3 6
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic 80.38  (20.71) 121.21  (22.13) 61.37  (26.23)
Diastolic 15.52  (14.10) 33.04  (24.69) 19.29  (17.31)
2.Primary Outcome
Title Serious Adverse Events
Hide Description Serious adverse events include: death, internal thoracic and abdominal injuries, device malfunction preventing use during CPR
Time Frame during the index CPR procedure (day 1), at hospital discharge, at 30 days, at three months, and at six months of follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACD-CPR +ITD S-CPR + ITPR S-CPR
Hide Arm/Group Description:
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: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
S-CPR: standard manual CPR
Overall Number of Participants Analyzed 18 16 14
Measure Type: Number
Unit of Measure: events
11 9 8
3.Secondary Outcome
Title Mean Intrathoracic Pressure (Airway Pressure)
Hide Description Intrathoracic pressures are reported relative to atmospheric pressure
Time Frame during CPR (day 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACD-CPR +ITD S-CPR + ITPR S-CPR
Hide Arm/Group Description:
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: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
S-CPR: standard manual CPR
Overall Number of Participants Analyzed 7 3 6
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.05  (2.40) -4.40  (3.25) 1.21  (2.57)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACD-CPR +ITD S-CPR + ITPR S-CPR
Hide Arm/Group Description 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: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR) S-CPR: standard manual CPR
All-Cause Mortality
ACD-CPR +ITD S-CPR + ITPR S-CPR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ACD-CPR +ITD S-CPR + ITPR S-CPR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/18 (55.56%)   8/16 (50.00%)   6/14 (42.86%) 
Cardiac disorders       
Re-arrest  2/18 (11.11%)  3/16 (18.75%)  0/14 (0.00%) 
Gastrointestinal disorders       
Vomiting  0/18 (0.00%)  1/16 (6.25%)  0/14 (0.00%) 
Investigations       
Device failure  1/18 (5.56%)  2/16 (12.50%)  0/14 (0.00%) 
Nervous system disorders       
Death  10/18 (55.56%)  8/16 (50.00%)  6/14 (42.86%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary edema  1/18 (5.56%)  1/16 (6.25%)  1/14 (7.14%) 
Blood in advanced airway  1/18 (5.56%)  1/16 (6.25%)  1/14 (7.14%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACD-CPR +ITD S-CPR + ITPR S-CPR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/18 (5.56%)   0/16 (0.00%)   1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders       
Blood in advanced airway  1/18 (5.56%)  0/16 (0.00%)  1/14 (7.14%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Research Associate
Organization: Advanced Circulatory
Phone: 651-403-5606
Publications:
Responsible Party: Advanced Circulatory Systems
ClinicalTrials.gov Identifier: NCT01325870     History of Changes
Other Study ID Numbers: 43-0566-000
2R44HL082088 ( U.S. NIH Grant/Contract )
First Submitted: March 28, 2011
First Posted: March 30, 2011
Results First Submitted: June 18, 2014
Results First Posted: July 17, 2014
Last Update Posted: August 12, 2016