Topic: Children, Cardiovascular disease
Conditions
Interventions
Eligible patients requiring PVR who give written informed consent to participate, will be randomised in a 1:1 ratio. Randomisation will be carried out using an internet-based system.
Group 1:: Parti
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing either: 1.1. Pulmonary valve replacement (PVR) or 1.2. Pulmonary valve replacement (PVR) with PFO closure that would not require CPB if using an injectable valve or 1.3. Pulmonary valve replacement (PVR) with RVOT reconstruction that does not require CPB if using an injectable valve 2. Patients aged 12-80 years old inclusive, with an adult valve size (2531mm)
Exclusion criteria
Exclusion criteria: 1. Prisoners and adults lacking capacity to consent 2. Patients aged 12 to 15 years old under the care of social services 3. Patients with pulmonary valve or artery stenosis requiring patch reconstruction of the pulmonary arteries using CPB 4. Patients having an intra-cardiac shunt that would require CPB despite using an injectable valve 5. Patients having a RVOT reconstruction that would require CPB despite using an injectable valve 6. Patients requiring other anatomical heart corrections that would require CPB despite using an injectable valve 7. Patients who are unwilling to undergo surgery involving a porcine product 8. Patients unable to provide assent/consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chest drainage in the first 24 post-operative hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Post-operative time-to-‘readiness for extubation’. The criteria below will be documented at the time of extubation (when all criteria should be met): normal temperature, cardiovascular system stable, no metabolic imbalance, blood loss decreasing and below a defined rate, able to clear respiratory secretions, patient awake, no residual muscle paralysis and adequate analgesia. 2. Length of ICU stay 3. Inotropic/vasodilator support 4. Chest drain volume in the first 0-12 hours 5. Blood products used in the first 24 hours 6. FFD, defined as all of: normal temperature, pulse and respiration, normal oxygen saturation on air, normal bowel function, physically mobile 7. Cardiac MRI assessment of valve and heart function at 6 months, defined as: presence and degree of pulmonary regurgitation, end-diastolic volume and right ventricular ejection fraction 8. Echocardiography assessment of valve function at routine follow-up at 6 months, defined as presence and degree of pulmonary regurgitation and residual valve stenosis, measured as peak velocity through the valve 9. Health-related quality of life is measured using the EuroQol EQ-5D (or EQ-5D-Y in patients 18 years) and child health questionnaire (CHQ, in patients <18 years) at 6 weeks, 6 months 10. Valve-related complications during follow-up | — |
Countries
England, United Kingdom
Contacts
Public ContactRachel Heys
Outcome results
None listed