Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation

NCT05948332 | Completed

• 1 other identifier: RVI_ECMO
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Consensus statements

  Consensus amongst the expert panel regarding RVI definition and management will be achieved using Delphi method which includes iterative rounds of questions; Consensus will be considered reached when a statement achieves \>80% of votes for multiple-choice questions and \>70% for Likert-scale statements

  Through study completion, an average of 6 months

Interventions

Delphi Rounds to generate consensus opinions among Experts BEHAVIORAL

The Investigators (Steering Committee) will select the experts from across the globe based on pre-specified qualification criteria and will conduct iterative Delphi rounds to generate consensus on the definition and management of acute RVI in patients with receiving V-V ECMO, among the Experts. The selection criteria will be self-assessed through a survey among the potential Experts.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthcare professionals involved in the management adult patients receiving Extracorporeal Membrane Oxygenation.

You may qualify if:

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

Sponsors & Collaborators

• Prashant Nasa: lead

Study Sites (1)

NMC Specialty Hospital, Al Nahda

Dubai, United Arab Emirates

Location

Related Publications (15)

• Nasa P, Azoulay E, Chakrabarti A, Divatia JV, Jain R, Rodrigues C, Rosenthal VD, Alhazzani W, Arabi YM, Bakker J, Bassetti M, De Waele J, Dimopoulos G, Du B, Einav S, Evans L, Finfer S, Guerin C, Hammond NE, Jaber S, Kleinpell RM, Koh Y, Kollef M, Levy MM, Machado FR, Mancebo J, Martin-Loeches I, Mer M, Niederman MS, Pelosi P, Perner A, Peter JV, Phua J, Piquilloud L, Pletz MW, Rhodes A, Schultz MJ, Singer M, Timsit JF, Venkatesh B, Vincent JL, Welte T, Myatra SN. Infection control in the intensive care unit: expert consensus statements for SARS-CoV-2 using a Delphi method. Lancet Infect Dis. 2022 Mar;22(3):e74-e87. doi: 10.1016/S1473-3099(21)00626-5. Epub 2021 Nov 10.

  PMID: 34774188 BACKGROUND

• Brodie D, Slutsky AS, Combes A. Extracorporeal Life Support for Adults With Respiratory Failure and Related Indications: A Review. JAMA. 2019 Aug 13;322(6):557-568. doi: 10.1001/jama.2019.9302.

  PMID: 31408142 BACKGROUND

• Supady A, Combes A, Barbaro RP, Camporota L, Diaz R, Fan E, Giani M, Hodgson C, Hough CL, Karagiannidis C, Kochanek M, Rabie AA, Riera J, Slutsky AS, Brodie D. Respiratory indications for ECMO: focus on COVID-19. Intensive Care Med. 2022 Oct;48(10):1326-1337. doi: 10.1007/s00134-022-06815-w. Epub 2022 Aug 9.

  PMID: 35945343 BACKGROUND

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 BACKGROUND

• Grasselli G, Calfee CS, Camporota L, Poole D, Amato MBP, Antonelli M, Arabi YM, Baroncelli F, Beitler JR, Bellani G, Bellingan G, Blackwood B, Bos LDJ, Brochard L, Brodie D, Burns KEA, Combes A, D'Arrigo S, De Backer D, Demoule A, Einav S, Fan E, Ferguson ND, Frat JP, Gattinoni L, Guerin C, Herridge MS, Hodgson C, Hough CL, Jaber S, Juffermans NP, Karagiannidis C, Kesecioglu J, Kwizera A, Laffey JG, Mancebo J, Matthay MA, McAuley DF, Mercat A, Meyer NJ, Moss M, Munshi L, Myatra SN, Ng Gong M, Papazian L, Patel BK, Pellegrini M, Perner A, Pesenti A, Piquilloud L, Qiu H, Ranieri MV, Riviello E, Slutsky AS, Stapleton RD, Summers C, Thompson TB, Valente Barbas CS, Villar J, Ware LB, Weiss B, Zampieri FG, Azoulay E, Cecconi M; European Society of Intensive Care Medicine Taskforce on ARDS. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023 Jul;49(7):727-759. doi: 10.1007/s00134-023-07050-7. Epub 2023 Jun 16.

  PMID: 37326646 BACKGROUND

• Riviello ED, Kiviri W, Twagirumugabe T, Mueller A, Banner-Goodspeed VM, Officer L, Novack V, Mutumwinka M, Talmor DS, Fowler RA. Hospital Incidence and Outcomes of the Acute Respiratory Distress Syndrome Using the Kigali Modification of the Berlin Definition. Am J Respir Crit Care Med. 2016 Jan 1;193(1):52-9. doi: 10.1164/rccm.201503-0584OC.

  PMID: 26352116 BACKGROUND

• Matthay MA, Thompson BT, Ware LB. The Berlin definition of acute respiratory distress syndrome: should patients receiving high-flow nasal oxygen be included? Lancet Respir Med. 2021 Aug;9(8):933-936. doi: 10.1016/S2213-2600(21)00105-3. Epub 2021 Apr 27.

  PMID: 33915103 BACKGROUND

• Sato R, Dugar S, Cheungpasitporn W, Schleicher M, Collier P, Vallabhajosyula S, Duggal A. The impact of right ventricular injury on the mortality in patients with acute respiratory distress syndrome: a systematic review and meta-analysis. Crit Care. 2021 May 21;25(1):172. doi: 10.1186/s13054-021-03591-9.

  PMID: 34020703 BACKGROUND

• Zochios V, Yusuff H, Schmidt M; Protecting the Right Ventricle Network (PRORVnet). Acute right ventricular injury phenotyping in ARDS. Intensive Care Med. 2023 Jan;49(1):99-102. doi: 10.1007/s00134-022-06904-w. Epub 2022 Oct 11. No abstract available.

  PMID: 36219228 BACKGROUND

• Huang S, Vignon P, Mekontso-Dessap A, Tran S, Prat G, Chew M, Balik M, Sanfilippo F, Banauch G, Clau-Terre F, Morelli A, De Backer D, Cholley B, Slama M, Charron C, Goudelin M, Bagate F, Bailly P, Blixt PJ, Masi P, Evrard B, Orde S, Mayo P, McLean AS, Vieillard-Baron A; ECHO-COVID research group. Echocardiography findings in COVID-19 patients admitted to intensive care units: a multi-national observational study (the ECHO-COVID study). Intensive Care Med. 2022 Jun;48(6):667-678. doi: 10.1007/s00134-022-06685-2. Epub 2022 Apr 21.

  PMID: 35445822 BACKGROUND

• Vieillard-Baron A, Naeije R, Haddad F, Bogaard HJ, Bull TM, Fletcher N, Lahm T, Magder S, Orde S, Schmidt G, Pinsky MR. Diagnostic workup, etiologies and management of acute right ventricle failure : A state-of-the-art paper. Intensive Care Med. 2018 Jun;44(6):774-790. doi: 10.1007/s00134-018-5172-2. Epub 2018 May 9.

  PMID: 29744563 BACKGROUND

• Vonk Noordegraaf A, Westerhof BE, Westerhof N. The Relationship Between the Right Ventricle and its Load in Pulmonary Hypertension. J Am Coll Cardiol. 2017 Jan 17;69(2):236-243. doi: 10.1016/j.jacc.2016.10.047.

  PMID: 28081831 BACKGROUND

• Chad T, Yusuff H, Zochios V, Pettenuzzo T, Fan E, Schmidt M; Protecting the Right Ventricle network (PRORVnet). Right Ventricular Injury Increases Mortality in Patients With Acute Respiratory Distress Syndrome on Veno-Venous Extracorporeal Membrane Oxygenation: A Systematic Review and Meta-Analysis. ASAIO J. 2023 Jan 1;69(1):e14-e22. doi: 10.1097/MAT.0000000000001854. Epub 2022 Nov 13.

  PMID: 36375040 BACKGROUND

• Dugar S, Sato R, Zochios V, Duggal A, Vallabhajosyula S; Protecting the Right Ventricle Network (PRORVnet). Defining Right Ventricular Dysfunction in Acute Respiratory Distress Syndrome. J Cardiothorac Vasc Anesth. 2022 Feb;36(2):632-634. doi: 10.1053/j.jvca.2021.09.001. Epub 2021 Sep 16. No abstract available.

  PMID: 34583852 BACKGROUND

• Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20.

  PMID: 34322364 RESULT

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction, Right; Respiratory Insufficiency; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Respiration Disorders; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Vasileios Zochios, MRCP FFICM

  University Hospitals of Leicester NHS Trust, Glenfied Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: HOD, Critical Care Medicine

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: July 17, 2023
• Study Start: September 1, 2023
• Primary Completion: November 26, 2023
• Study Completion: January 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)