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

August 2, 2017 updated by: Lars Wik, Physio-Control

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0467
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LUCAS 2 AD
LUCAS 2 AD will be used for CPR
Device: LUCAS2 AD
LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.
Other: LUCAS2
LUCAS2 will be used for CPR
Device: LUCAS2 AD
LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemodynamics measured as EtCO2
Time Frame: During 30 minutes of CPR
During 30 minutes of CPR

Secondary Outcome Measures

Outcome Measure
Time Frame
Intra arterial blood pressures,
Time Frame: During 30 minutes of CPR
During 30 minutes of CPR
Oximetry,
Time Frame: During 30 minutes of CPR
During 30 minutes of CPR
ROSC (Return of spontaneous circulation)
Time Frame: During CPR
During CPR
safety
Time Frame: During 30 minutes of CPR
During 30 minutes of CPR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Physio-Control

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Lars Wik, MD, PhD, Oslo Universitetssykehus. Ullevål, Norway.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol ID 11, March 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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