Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552312
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
A Modified Delphi for ECPR Post Resuscitation Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ECPR Post Resuscitation Care an International Consensus Statement Via Modified Delphi Approach
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to generate expert consensus statements on the management of out of hospital cardiac arrest patients treated with extracorporeal membrane oxygenation ECMO cardiopulmonary resuscitation ECPR
Detailed Description:
The study will be performed using a modified Delphi process with an international expert panel to generate recommendation statements related to the management of patients treated with ECPR and to determine the level of agreement for each statement from the panel as a whole The following topics will be covered
Sedation Mechanical ventilation management Oxygen management Carbon dioxide management Haemodynamic management ECMO flow management Mean arterial pressure targets Aortic valve not opening management Left ventricular unloadingventing Complication management Infection prevention Anticoagulation Imaging Prognostication and neuro-prognostication Practical recommendations Organ donation Patient followup
Cannulation will not be covered as this has been covered in other Delphi processes
Management Consensus is achieved through iterative rounds of survey and revision to the statements until a pre-determined level of agreement is met 70 agreement
Part 1 planning and evidence review Series of planning sessions with co-chairs Literature is reviewedsummarized Initial statements will be developed based on evidence and study team expertise
Expert panel selection
The study team 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 To avoid any bias the study team will not participate in the voting process The survey and voting process will be online and anonymous to avoid any reciprocal influence
Part 2 Survey to achieve consensus Survey based on the initial statements developed by study team will be developed This will be reviewed by independent contributors not part of the study team or the expert panel to ensure validity appropriate topic coverage and length
Some questions will enable a YesNo or quantitative response Others will be utilising a Likert scale The voting process will be anonymous to avoid any reciprocal influence or dredging effects and done with Research and DevelopmentUniversity of California Los Angeles RANDUCLA Appropriateness Method Scale
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 wordingphrasing changes and to suggest any additional items for inclusion
Based on a previously established Delphi method approach consensus will be achieved when an item reached a high level of agreement for inclusion High level of agreement will require greater than 70 of the survey responses for a particular item meeting a score of strong agreement ie a score 7 on the Likert scale A medium level of agreement will be defined between 60 and 70 and low agreement below 60 Each expert will receive anonymized aggregate statistics group mean group standard deviation percentage agreement in addition to their own individual ratings for each item Statements achieving a high level of agreement in the first survey ie a score of 70 of respondents with a score 7 will not be reviewed in the consensus meeting nor in the second survey Those not meeting a high level of agreement will be rephased during the online meeting If 70 of respondents score a statement at 3 on the 9-point scale or less for a statement in the first-round survey that statement will be deemed not important and removed and not discussed at the online discussion
An online consensus meeting will be arranged after the first round where the expert panel will discuss the items in detail including comments on the first survey Modifications to questions will be possible at this meeting
Following the online consensus meeting a final survey will be prepared and sent to each expert This survey will include each item with comments indicating changes made during the consensus meeting as well as the mean score and level of agreement low medium high for each item from the first survey excluding statements of low importanceagreement as defined above Expert participants will again rate each item on the same 9-point Likert scale Descriptive statistics including median IQR and level of agreement will be obtained for each item from the final survey Items that reach a high level of agreement will be included in the final list of consensuses Items that reached medium or low agreement will be discarded after the final round
Revised statements attaining strong agreement after the second round will be classified as weak agreement The percentage agreement will be quantified as the number of individual scores of more than 7 divided by the number of voting experts Given the poor- and low-quality data available on many aspects of topic the study team will not be using the Grading of Recommendation Assessment Development and Evaluation GRADE to prepare statements but will referrer to the Appraisal of Guidelines for Research and evaluation AGREE statement This approach is consistent with other recently published ECMO guidelines
Sedation Mechanical ventilation management Oxygen management Carbon dioxide management Haemodynamic management ECMO flow management Mean arterial pressure targets Aortic valve not opening management Left ventricular unloadingventing Complication management Infection prevention Anticoagulation Imaging Prognostication and neuro-prognostication Practical recommendations Organ donation Patient followup
Cannulation will not be covered as this has been covered in other Delphi processes
Management Consensus is achieved through iterative rounds of survey and revision to the statements until a pre-determined level of agreement is met 70 agreement
Part 1 planning and evidence review Series of planning sessions with co-chairs Literature is reviewedsummarized Initial statements will be developed based on evidence and study team expertise
Expert panel selection
The study team 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 To avoid any bias the study team will not participate in the voting process The survey and voting process will be online and anonymous to avoid any reciprocal influence
Part 2 Survey to achieve consensus Survey based on the initial statements developed by study team will be developed This will be reviewed by independent contributors not part of the study team or the expert panel to ensure validity appropriate topic coverage and length
Some questions will enable a YesNo or quantitative response Others will be utilising a Likert scale The voting process will be anonymous to avoid any reciprocal influence or dredging effects and done with Research and DevelopmentUniversity of California Los Angeles RANDUCLA Appropriateness Method Scale
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 wordingphrasing changes and to suggest any additional items for inclusion
Based on a previously established Delphi method approach consensus will be achieved when an item reached a high level of agreement for inclusion High level of agreement will require greater than 70 of the survey responses for a particular item meeting a score of strong agreement ie a score 7 on the Likert scale A medium level of agreement will be defined between 60 and 70 and low agreement below 60 Each expert will receive anonymized aggregate statistics group mean group standard deviation percentage agreement in addition to their own individual ratings for each item Statements achieving a high level of agreement in the first survey ie a score of 70 of respondents with a score 7 will not be reviewed in the consensus meeting nor in the second survey Those not meeting a high level of agreement will be rephased during the online meeting If 70 of respondents score a statement at 3 on the 9-point scale or less for a statement in the first-round survey that statement will be deemed not important and removed and not discussed at the online discussion
An online consensus meeting will be arranged after the first round where the expert panel will discuss the items in detail including comments on the first survey Modifications to questions will be possible at this meeting
Following the online consensus meeting a final survey will be prepared and sent to each expert This survey will include each item with comments indicating changes made during the consensus meeting as well as the mean score and level of agreement low medium high for each item from the first survey excluding statements of low importanceagreement as defined above Expert participants will again rate each item on the same 9-point Likert scale Descriptive statistics including median IQR and level of agreement will be obtained for each item from the final survey Items that reach a high level of agreement will be included in the final list of consensuses Items that reached medium or low agreement will be discarded after the final round
Revised statements attaining strong agreement after the second round will be classified as weak agreement The percentage agreement will be quantified as the number of individual scores of more than 7 divided by the number of voting experts Given the poor- and low-quality data available on many aspects of topic the study team will not be using the Grading of Recommendation Assessment Development and Evaluation GRADE to prepare statements but will referrer to the Appraisal of Guidelines for Research and evaluation AGREE statement This approach is consistent with other recently published ECMO guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None