NCT06552312

Brief Summary

The objective of this study is to generate expert consensus statements on the management of out of hospital cardiac arrest (OHCA) patients treated with extracorporeal membrane oxygenation (ECMO) cardiopulmonary resuscitation (ECPR).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

August 10, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

August 10, 2024

Last Update Submit

May 14, 2025

Conditions

Keywords

Extracorporeal membrane oxygenation (ECMO)Extracorporeal membrane oxygenation cardiopulmonary resuscitation (ECPR)

Outcome Measures

Primary Outcomes (1)

  • Degree of consensus

    The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 70% of the panel rating a given statement \>7 on a likert scale between 1-9

    Six months

Study Arms (1)

Delphi Panel

The Delphi panel will include between 20-50 international experts in critical care, cardiology, intensive care, anaesthesia, emergency medicine, perfusion and cardio-thoracic surgery.

Other: Delphi Questionnaire

Interventions

Experts will be asked to rate the importance of each item for ECPR for OHCA using the Grading of Recommendations Assessment, Development and evaluation scale from 1 (strongly disagree) to 9 (strongly agree). Statements will be classified as strong agreement (median score 7-9), neither agree or disagree (median score 4-6), or strongly disagree (median score 1-3). Panel members were also provided an "Unable to Score" response to use if they did not feel comfortable rating any specific domain. Recipients will be asked to recommend any wording/phrasing changes and to suggest any additional items for inclusion.

Delphi Panel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Internationally recognised experts in extracorporeal membrane oxygenation cardiopulmonary resuscitation (ECPR) and Out of Hospital Cardiac Arrest (OHCA).

You may qualify if:

  • Identified experts on ECPR for OHCA based on contributions to the field, clinical experiences, range of specialties and peer-reviewed publications with prioritization of diversity in geography and expertise. Using snowball sampling, we asked the recruited experts to identify additional content experts to participate in the expert panel. We will aim to recruit a total of 50 experts, in accordance with the recommended panel number of \>30 as outlined in the original Delphi method paper.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sydney Local Health District

Sydney, New South Wales, 2050, Australia

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2024

First Posted

August 14, 2024

Study Start

October 30, 2024

Primary Completion

September 30, 2025

Study Completion

October 30, 2025

Last Updated

May 18, 2025

Record last verified: 2025-05

Locations