Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06552312




Registration number
NCT06552312
Ethics application status
Date submitted
10/08/2024
Date registered
14/08/2024
Date last updated
14/08/2024

Titles & IDs
Public title
A Modified Delphi for ECPR Post Resuscitation Care
Scientific title
ECPR Post Resuscitation Care an International Consensus Statement Via Modified Delphi Approach
Secondary ID [1] 0 0
TBA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Delphi Questionnaire

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 interventions: Delphi Questionnaire
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). The median score (IQR) will be calculated after eliminating one lowest and one highest value after each survey round. 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Degree of consensus
Timepoint [1] 0 0
Six months

Eligibility
Key inclusion criteria
Inclusion:

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Study team members.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Local Health District - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mark Dennis
Address 0 0
Country 0 0
Phone 0 0
61400701265
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06552312