Clinical trial NCT05948332: Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
Official title: Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation for Respiratory Support Using the Delphi Method: A PRORVnet - Expert Consensus Statements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Circulation; Complications
Extracorporeal Membrane Oxygenation Complication
Right Heart Failure
Right Ventricular Dysfunction
Respiratory Failure
Respiratory Distress Syndrome
Keywords: Extracorporeal Membrane Oxygenation
Heart Failure
Right Ventricular Injury
Respiratory Distress Syndrome
Lead sponsor: NMC Specialty Hospital
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare professionals involved in the management adult patients receiving Extracorporeal Membrane Oxygenation.

Brief summary: The aim of this study is to identify existing definitions and therapeutic approaches for acute right ventricular injury (RVI) in patients receiving extracorporeal membrane oxygenation (ECMO) for respiratory support. The objective of the study is to generate expert consensus statements on the definition and management of acute RVI in this high-risk patient population, using a Delphi method. The standardised RVI definition during ECMO for respiratory support and a consensus-based management approach to RVI will facilitate systematic aggregation of data across clinical trials to harmonise patient selection and compare therapeutic interventions.

Detailed description: Extracorporeal membrane oxygenation (ECMO) is increasingly being used as part of the algorithm for the management of patients with respiratory failure in whom conventional ventilatory strategies have failed to preserve gas exchange without use of settings that may result in ventilator-induced lung injury. ECMO for respiratory support may be required in critically ill patients with any of the following types of respiratory failure: a) acute respiratory distress syndrome (ARDS) of any aetiology (infectious or non-infectious, pulmonary or extrapulmonary), defined according to the Berlin criteria of ARDS, or the more recently proposed Kigali modification and the New Global definition of ARDS; b) acute reversible hypoxemic and/or hypercapnic respiratory failure of any infectious or non-infectious aetiology (including pulmonary embolism and primary graft failure in lung transplantation recipients); and c) chronic hypoxemic and/or hypercapnic respiratory failure, as a bridge to lung transplantation strategy. Right ventricular injury (RVI) may develop in the context of any of the aforementioned types of respiratory failure and is characterised by a spectrum of abnormal RV biomechanics which all have been linked to mortality. One of the main mechanisms of RVI in patients with respiratory failure is pulmonary vasoconstriction caused by hypoxaemia and/or hypercapnic acidaemia leading to elevated RV afterload. Respiratory ECMO supports or replaces pulmonary gas exchange and theoretically may reverse the aforementioned mechanism of RVI and unloads the RV. However, RVI may persist or worsen despite application of ECMO and is strongly associated with significant mortality.

There is currently no universally accepted definition for RVI in patients receiving ECMO for respiratory support or evidence-based RV-targeted therapies. This may result in underdiagnosis of this clinical entity and clinical practice variations and hence there is a need to standardise diagnostic criteria as well as clarify therapeutic management. The objective of the current investigation is to generate consensus statements by experts on the definition and management of RVI in adult patients receiving ECMO for respiratory support, using a Delphi process.

The Delphi process is a well-known mechanism for generating consensus on a specific topic by tapping into the "collective intelligence" of the panel members. The Steering Committee members conduct iterative Delphi rounds to obtain an agreement among the Experts after completing a literature search on the currently available evidence and preparing the opening statements. The members of the Steering Committee will not take part in the Delphi surveys.

The investigators will be using a modified Delphi-based methodology involving global experts from different disciplines (intensive care medicine, anaesthesia, cardiac surgery, cardiology, or a combination of two or more specialties) who meet pre-specified qualification criteria. A survey will be sent to all potential panel members prior to commencement of the Delphi rounds, to ascertain expertise in the field. The entire study will be conducted through approximately three or four rounds of Google Forms-based Delphi questionnaires. The Experts will provide opinion on the problem areas; definition and management of acute RVI in patients receiving ECMO for respiratory support. The survey is organised into three domains: Definition, RVI severity, Management strategies, and Research Priorities. The problem areas, domains and statements were generated by systematic literature review. Most of these statements require a 7-point Likert scale rating or selecting appropriate options in multiple-choice questions (MCQs). In round one, there is an option to collect feedback from participating Experts in the offered open area, which will be evaluated before the round two questionnaire. Rounds are repeated until consensus (or stable dissensus) is reached (≥70% for the Likert scale and ≥80% for MCQs). Experts will be presented with the summary results of each round, and the survey procedure will be repeated with the amended questionnaire. The Delphi rounds will continue until the required consensus (or lack thereof) and statement stability is obtained.

Eligibility criteria: Inclusion Criteria:

1. Working in an active Extracorporeal Life Support Organisation (ELSO) member centre for \> 5 years, or clinical experience in cardiorespiratory failure for \> 5 years.
2. Original research in the field of ECMO or Cardiorespiratory failure (at least one peer-reviewed publication as a leading author).

Exclusion Criteria:

People who do not meet inclusion criteria.

Primary outcomes:
measure: Consensus statements
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: NMC Specialty Hospital, Al Nahda
Study officials:
affiliation: University Hospitals of Leicester NHS Trust, Glenfied Hospital
name: Vasileios Zochios, MRCP FFICM
role: PRINCIPAL_INVESTIGATOR
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