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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    ACD-CPR +ITD   S-CPR + ITPR   S-CPR
STARTED   18   16   14 
COMPLETED   7   3   6 
NOT COMPLETED   11   13   8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   ACD-CPR +ITD   S-CPR + ITPR   S-CPR   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   16   14   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.1  (14.6)   66.8  (18.9)   64.7  (14.0)   64.8  (15.8) 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   10   5   7   22 
>=65 years   8   11   7   26 
Gender 
[Units: Participants]
       
Female   10   7   5   22 
Male   8   9   9   26 
Region of Enrollment 
[Units: Participants]
       
United States   18   16   14   48 


  Outcome Measures

1.  Primary:   Mean Systolic and Diastolic Blood Pressures   [ Time Frame: during CPR (day 1) ]

2.  Primary:   Serious Adverse Events   [ 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 ]

3.  Secondary:   Mean Intrathoracic Pressure (Airway Pressure)   [ Time Frame: during CPR (day 1) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: nburkhart@advancedcirculatory.com


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