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NCT02479152 Clinical Trial

The Haemodynamic Effects of Mechanical Standard and Active Chest Compression-decompression During Out-of-hospital CPR

Cardiac Arrest Clinical Trial

Official title:
The Haemodynamic Effects of Mechanical Standard and Active External Chest Compression-decompression During Out-of-hospital Cardiopulmonary Resuscitation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02479152
Other study ID # Protocol ID 11, March 2015
Secondary ID
Status Completed
Phase N/A
First received April 13, 2015
Last updated August 2, 2017
Start date April 2015
Est. completion date April 2017

Study information
Verified date August 2017
Source Physio-Control
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this randomized out-of-hospital cardiopulmonary resuscitation study is to investigate haemodynamics generated by the standard mechanical external chest compression device (LUCAS™ 2) compared to a new version generating chest compressions and active decompression above the initial starting position of the suction cup (LUCAS™ 2AD).

Description:

Based on randomization patients will receive standard or active compression decompression chest compression and the haemodynamic effects will be compared.

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Unexpected adult out-of-hospital non-traumatic cardiac arrest where an attempt of resuscitation is considered appropriate in:

- Patients 18 years or older

Exclusion Criteria:

- Traumatic cardiac arrest

- Age believed to be less than 18 years

- Known pregnancy

- Victim not to be resuscitated (DNR orders)

- Internals in prison

- Included once in the study already

- To Small/Large patients

- Sustained ROSC occurring before the LUCAS™ 2 or LUCAS™ 2-AD can be applied to the patient, such that further CPR is not needed

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• LUCAS2 AD
LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.

Locations
Country Name City State
Norway Oslo University hospital Oslo

Sponsors (2)
Lead Sponsor Collaborator
Physio-Control GE Healthcare

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemodynamics measured as EtCO2 During 30 minutes of CPR
Secondary Intra arterial blood pressures, During 30 minutes of CPR
Secondary Oximetry, During 30 minutes of CPR
Secondary ROSC (Return of spontaneous circulation) During CPR
Secondary safety During 30 minutes of CPR
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