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Right Heart Injury Monitoring on ECMO

Feasibility Study for Monitoring Right Ventricular Injury in Patients With Severe Acute Respiratory Failure Supported With Veno-venous Extracorporeal Membrane Oxygenation

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07880730
Acronym
RHIME
Enrollment
30
Registered
2026-10-19
Start date
2026-11-01
Completion date
2028-01-01
Last updated
2026-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

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.

Sponsors

Papworth Hospital NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of RVI monitoring protocol2 monthsEvaluate 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.

Secondary

MeasureTime frameDescription
Echocardiography and biomarkers data2 monthsDescribe how specific RV echocardiographic parameters and biomarkers evolve over the course of VV-ECMO support.
Description of groups of patients12 monthsDescribe 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
Changes in patient's management2 monthsDescribe any changes in patient's management that were triggered by the results of the twice-weekly RVI monitoring protocol.

Countries

United Kingdom

Contacts

CONTACTAna Francisca Caetano
ana.caetano@nhs.net044 + (0)7476788807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 20, 2026