Acute Respiratory Distress Syndrome (ARDS)RHIMENCT07880730
Right Heart Injury Monitoring on ECMO
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Acute Respiratory Failure (ARF), run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to find out whether it is practical to introduce a consistent monitoring approach to the right side of the heart in patients supported with VV-ECMO. VV-ECMO is a life support machine that takes over the work of the lungs to give them time to recover. It is used when lung injury is life-threatening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure (ARF), Right Heart Failure, Unspecified
- What is being tested?
- Transthoracic echocardiogram, High sensitivity troponin and N-terminal pro-B-type natriuretic peptide
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2026to Jan 2028
- How long will I take part?
- 2 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We aim to enrol consecutive patients, supported with VV-ECMO due to SARF at Royal Papworth Hospital Critical Care Area, and for whom consent has been obtained.
Who may be able to join
- Adults (≥18 years old)
- Less than 72 hours after being established on VV-ECMO due to SARF (either retrieved to RPH from another hospital or already an inpatient at RPH)
Who cannot join
- Patients <18 years old
- Patients that had been previously included in this study
- Patients requiring VV-ECMO support post pulmonary thrombo-endarterectomy, as a bridge to lung transplantation or post lung-transplantation
- Any other reason for VV-ECMO support that is not SARF
- Patients and/or Personal Consultee not fluent in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0AY
Ana Francisca Caetano, 044 + (0)7476788807, ana.caetano@nhs.net
About this study
Official title: Feasibility Study for Monitoring Right Ventricular Injury in Patients With Severe Acute Respiratory Failure Supported With Veno-venous Extracorporeal Membrane Oxygenation
This study aims to find out whether it is practical to introduce a consistent monitoring approach to the right side of the heart in patients supported with VV-ECMO.
VV-ECMO is a life support machine that takes over the work of the lungs to give them time to recover. It is used when lung injury is life-threatening.
Whilst receiving VV-ECMO support, in addition to the current standard of care, the following will be performed twice weekly:
- Heart scan (echocardiogram)
- Blood tests (hs-troponin and NT-proBNP)
The patient's involvement in the study lasts for as long as they are on the life support machine, plus one final heart scan 48 hours after it is removed.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure (ARF), Right Heart Failure, Unspecified
- Being tested
- Transthoracic echocardiogram, High sensitivity troponin, N-terminal pro-B-type natriuretic peptide
- Medical subject headings
- Respiratory Distress Syndrome, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiogramDiagnostic test
Transthoracic echocardiogram with a dedicated RV protocol
High sensitivity troponinDiagnostic test
Twice weekly measurements
N-terminal pro-B-type natriuretic peptideDiagnostic test
Twice weekly measurement.
| Study group | Role | What they receive |
|---|---|---|
| SARF | Patients supported with VV-ECMO due to severe acute respiratory failure. Receives: Diagnostic Test: Transthoracic echocardiogram; Diagnostic Test: High sensitivity troponin; Diagnostic Test: N-terminal pro-B-type natriuretic peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of RVI monitoring protocol
Evaluate the feasibility of implementing a multimodal protocol for monitoring RVI in patients supported with VV-ECMO for severe acute respiratory failure at Royal Papworth Hospital Critical Care Area.
Measured: 2 months
Secondary outcomes (3)
Echocardiography and biomarkers data
Describe how specific RV echocardiographic parameters and biomarkers evolve over the course of VV-ECMO support.
Measured: 2 months
Description of groups of patients
Describe the following groups of patients:
- With and without RVI
- With and without early-RVI
- With and without late-RVI
- With mild, moderate and severe RVI
- With RVI that meets and does not meet flow demand
Measured: 12 months
Changes in patient's management
Describe any changes in patient's management that were triggered by the results of the twice-weekly RVI monitoring protocol.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880730
- Sponsor's protocol ID
- SP03264
- Acronym
- RHIME
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Robinson S, Rana B, Oxborough D, Steeds R, Monaghan M, Stout M, Pearce K, Harkness A, Ring L, Paton M, Akhtar W, Bedair R, Bhattacharyya S, Collins K, Oxley C, Sandoval J, Schofield MBChB R, Siva A, Parker K, Willis J, Augustine DX. A practical guideline for performing a comprehensive transthoracic echocardiogram in adults: the British Society of Echocardiography minimum dataset. Echo Res Pract. 2020 Dec;7(4):G59-G93. doi: 10.1530/ERP-20-0026.
PubMed 33112828McDonald R, Fowles JA, Gatherer R, Caetano F. Right ventricular injury during VV-ECMO for severe ARDS: Does time matter? J Intensive Care Soc. 2025 Sep 24;27(1):82-84. doi: 10.1177/17511437251374821. eCollection 2026 Feb.
PubMed 41018561Chad 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.
PubMed 36375040Zochios V, Nasa P, Yusuff H, Schultz MJ, Antonini MV, Duggal A, Dugar S, Ramanathan K, Shekar K, Schmidt M; RVI-ECMO Delphi Expert group; Protecting the Right Ventricle network (PRORVnet). Definition and management of right ventricular injury in adult patients receiving extracorporeal membrane oxygenation for respiratory support using the Delphi method: a PRORVnet study. Expert position statements. Intensive Care Med. 2024 Sep;50(9):1411-1425. doi: 10.1007/s00134-024-07551-z. Epub 2024 Aug 5.
PubMed 39102027