The Haemodynamic Effects of Mechanical Standard and Activ... | NCT02479152

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

NCT02479152

Sponsor

Physio-Control

Status

Completed

Last Update Posted

Aug 4, 2017Actual

Enrollment

126Actual

Phase

Not Applicable

Conditions

Cardiac Arrest

Interventions

LUCAS2 AD

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015Actual

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Apr 13, 2015

First Submission Date that Met QC Criteria

Jun 23, 2015

First Posted Date

Jun 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2017

Last Update Posted Date

Aug 4, 2017Actual

Name	Class
GE Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LUCAS 2 AD	Active Comparator	LUCAS 2 AD will be used for CPR	Device: LUCAS2 AD
LUCAS2	Other	LUCAS2 will be used for CPR	Device: LUCAS2 AD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LUCAS2 AD	Device	LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.	LUCAS 2 AD LUCAS2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Wik, MD, PhD	Oslo Universitetssykehus. Ullevål, Norway.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University hospital		Oslo		0467	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34710550	Derived	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases