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CompletedNCT02479152Updated Aug 4, 2017

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

An interventional study of LUCAS2 AD in Cardiac Arrest, sponsored by Physio-Control. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-04.

Sponsored by Physio-Control · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

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

02

Conditions studied

  • Cardiac Arrest

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Keywords

  • Mechanical CPR
  • Hemodynamics
03

In context

Heart Arrest

965 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.

This study's enrollment of 126 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

This is the only study on the registry with Physio-Control as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
126 participants (actual)

Study arms

  • Active comparator
    LUCAS 2 AD

    LUCAS 2 AD will be used for CPR

    Device: LUCAS2 AD

  • Other
    LUCAS2

    LUCAS2 will be used for CPR

    Device: LUCAS2 AD

Interventions

  • DeviceLUCAS2 AD

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

06

What researchers measure

Primary outcomes

  1. Hemodynamics measured as EtCO2

    Time frame: During 30 minutes of CPR

Secondary outcomes

  1. Intra arterial blood pressures,

    Time frame: During 30 minutes of CPR

  2. Oximetry,

    Time frame: During 30 minutes of CPR

  3. ROSC (Return of spontaneous circulation)

    Time frame: During CPR

  4. safety

    Time frame: During 30 minutes of CPR

07

Study locations

1 site
  • Oslo University hospital
    Oslo, 0467, Norway
08

References and documents

Publications

  • 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. PubMed 34710550 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02479152
Lead sponsor
Physio-Control
Collaborators
GE Healthcare
Responsible party
Lars Wik (MD, PhD, Ullevaal University Hospital) — Principal investigator
First posted
Jun 24, 2015
Start date
Apr 2015
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Aug 4, 2017

Study contacts

Lars Wik, MD, PhD
principal investigator · Oslo Universitetssykehus. Ullevål, Norway.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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