The Haemodynamic Effects of Mechanical Standard and Active Chest Compression-decompression During Out-of-hospital CPR
1 other identifier
interventional
126
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedAugust 4, 2017
August 1, 2017
2 years
April 13, 2015
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemodynamics measured as EtCO2
During 30 minutes of CPR
Secondary Outcomes (4)
Intra arterial blood pressures,
During 30 minutes of CPR
Oximetry,
During 30 minutes of CPR
ROSC (Return of spontaneous circulation)
During CPR
safety
During 30 minutes of CPR
Study Arms (2)
LUCAS 2 AD
ACTIVE COMPARATORLUCAS 2 AD will be used for CPR
LUCAS2
OTHERLUCAS2 will be used for CPR
Interventions
LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.
Eligibility Criteria
You may qualify if:
- Unexpected adult out-of-hospital non-traumatic cardiac arrest where an attempt of resuscitation is considered appropriate in:
- Patients 18 years or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Physio-Controllead
- GE Healthcarecollaborator
Study Sites (1)
Oslo University hospital
Oslo, 0467, Norway
Related Publications (1)
Berve PO, Hardig BM, Skalhegg T, Kongsgaard H, Kramer-Johansen J, Wik L. Mechanical active compression-decompression versus standard mechanical cardiopulmonary resuscitation: A randomised haemodynamic out-of-hospital cardiac arrest study. Resuscitation. 2022 Jan;170:1-10. doi: 10.1016/j.resuscitation.2021.10.026. Epub 2021 Oct 25.
PMID: 34710550DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars Wik, MD, PhD
Oslo Universitetssykehus. Ullevål, Norway.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 13, 2015
First Posted
June 24, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
August 4, 2017
Record last verified: 2017-08