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

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
LUCAS2 AD
Sponsored by
Physio-Control
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Mechanical CPR, Hemodynamics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

LUCAS 2 AD

LUCAS2

Arm Description

LUCAS 2 AD will be used for CPR

LUCAS2 will be used for CPR

Outcomes

Primary Outcome Measures

Hemodynamics measured as EtCO2

Secondary Outcome Measures

Intra arterial blood pressures,
Oximetry,
ROSC (Return of spontaneous circulation)
safety

Full Information

First Posted
April 13, 2015
Last Updated
August 2, 2017
Sponsor
Physio-Control
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02479152
Brief Title
The Haemodynamic Effects of Mechanical Standard and Active Chest Compression-decompression During Out-of-hospital CPR
Official Title
The Haemodynamic Effects of Mechanical Standard and Active External Chest Compression-decompression During Out-of-hospital Cardiopulmonary Resuscitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Physio-Control
Collaborators
GE Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Mechanical CPR, Hemodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LUCAS 2 AD
Arm Type
Active Comparator
Arm Description
LUCAS 2 AD will be used for CPR
Arm Title
LUCAS2
Arm Type
Other
Arm Description
LUCAS2 will be used for CPR
Intervention Type
Device
Intervention Name(s)
LUCAS2 AD
Intervention Description
LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.
Primary Outcome Measure Information:
Title
Hemodynamics measured as EtCO2
Time Frame
During 30 minutes of CPR
Secondary Outcome Measure Information:
Title
Intra arterial blood pressures,
Time Frame
During 30 minutes of CPR
Title
Oximetry,
Time Frame
During 30 minutes of CPR
Title
ROSC (Return of spontaneous circulation)
Time Frame
During CPR
Title
safety
Time Frame
During 30 minutes of CPR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Wik, MD, PhD
Organizational Affiliation
Oslo Universitetssykehus. Ullevål, Norway.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University hospital
City
Oslo
ZIP/Postal Code
0467
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34710550
Citation
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.
Results Reference
derived

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

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