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Not yet recruitingNCT07880730RHIMEUpdated Oct 19, 2026

Right Heart Injury Monitoring on ECMO

An observational study in Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure (ARF) and Right Heart Failure, Unspecified, sponsored by Papworth Hospital NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Papworth Hospital NHS Foundation Trust · Observational

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Acute Respiratory Distress Syndrome (ARDS)
  • Acute Respiratory Failure (ARF)
  • Right Heart Failure, Unspecified
03

In context

Respiratory Distress Syndrome

1,619 studies on the registry are indexed under Respiratory Distress Syndrome; 319 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 548 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Papworth Hospital NHS Foundation Trust is the lead sponsor of 63 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
2 Months
Patient registry
Yes

Groups and cohorts

  • SARF

    Patients supported with VV-ECMO due to severe acute respiratory failure.

    Diagnostic Test: Transthoracic echocardiogram · Diagnostic Test: High sensitivity troponin · Diagnostic Test: N-terminal pro-B-type natriuretic peptide

Interventions

  • Diagnostic testTransthoracic echocardiogram

    Transthoracic echocardiogram with a dedicated RV protocol

  • Diagnostic testHigh sensitivity troponin

    Twice weekly measurements

  • Diagnostic testN-terminal pro-B-type natriuretic peptide

    Twice weekly measurement.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

Secondary outcomes

  1. Echocardiography and biomarkers data

    Describe how specific RV echocardiographic parameters and biomarkers evolve over the course of VV-ECMO support.

    Time frame: 2 months

  2. Description of groups of patients

    Describe the following groups of patients: 1. With and without RVI 2. With and without early-RVI 3. With and without late-RVI 4. With mild, moderate and severe RVI 5. With RVI that meets and does not meet flow demand

    Time frame: 12 months

  3. 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.

    Time frame: 2 months

Other outcomes

  1. Predictors of RVI

    Can regular monitoring of biomarkers of heart strain (hs-troponin and NT-proBNP) and/or of haemodynamic echocardiographic parameters (pulmonary artery flow acceleration time, RV t-IVT and RV/PA coupling) enable earlier identification of patients who: 1. Will recover from early-RVI when VV-ECMO is started? 2. Will develop RVI whilst on VV-ECMO (late-RVI)? 3. Will develop clinically relevant RVI phenotypes (RV meets or does not meet flow demand)?

    Time frame: 12 months

  2. Markers of heart strain to predict RVI

    Can hs-troponin and NT-proBNP identify patients that will fulfil echocardiographic criteria of RVI?

    Time frame: 12 months

  3. VV-ECMO outcomes and RVI

    Are there differences in clinical outcomes (VV-ECMO length, VV-ECMO outcome and CCA length of stay) between patients with: 1. E-RVI and L-RVI? 2. Different RVI phenotypes (mild, moderate and severe)?

    Time frame: 12 months

  4. RVI monitoring protocol and clinical practice

    Are the clinicians integrating the results of the RVI monitoring protocol into their clinical decision-making process?

    Time frame: 12 months

07

Study locations

1 site
  • Royal Papworth Hospital NHS Foundation Trust
    Cambridge, Cambridgeshire CB2 0AY, United Kingdom
08

References and documents

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 33112828 ↗
  • McDonald 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 41018561 ↗
  • 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. PubMed 36375040 ↗
  • Zochios 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 ↗

Study documents

  • Study protocol · May 26, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07880730
Lead sponsor
Papworth Hospital NHS Foundation Trust
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Oct 19, 2026

Study contacts

Ana Francisca Caetano
Contact
ana.caetano@nhs.net
044 + (0)7476788807

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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