Observing recovery from weakness after severe respiratory and cardiac failure
Prospective Observational Study Regarding the Determinants of Functional Disability and Quality of Life in Patients Recovering From Severe Acute Cardiac or Respiratory Failure Considered for Mechanical Cardiorespiratory Support (CLEVERER)
This study looks at how people who had severe breathing and heart problems recover from weakness after being in intensive care and on a special life-support machine, to see what helps or hinders their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barts & The London NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT03753412 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to identify the factors influencing recovery from intensive care unit-acquired weakness (ICUAW) in patients who have experienced severe cardiorespiratory failure and required extra-corporeal membrane oxygenation (ECMO). The study will assess the impact of ICUAW on physical function and health-related quality of life (HRQoL) following critical illness. By examining real-life cases, the research seeks to uncover the determinants of recovery and the associated risks of ICUAW, which can significantly affect patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have experienced severe cardiorespiratory failure requiring ECMO.
Not a fit: Patients with previous strokes, neuromuscular diseases, malignancies, or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery strategies for patients suffering from ICUAW, enhancing their physical function and quality of life.
How similar studies have performed: While the phenomenon of ICUAW has been recognized, this study aims to explore its determinants in a specific patient population, making it a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Above the age of 18 * Adults with severe cardio-respiratory failure requiring ECMO. * Adults who have had personal and professional consultees agree to enrol them in the trial. Exclusion criteria: * Previous Stroke * Neuromuscular disease * Malignancy * Underlying neuromuscular disease * paediatrics
Where this trial is running
London
- St Bartholomew's hospital (Barts NHS trust) — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mark Griffiths, PhD FRCP — Substantive Employee and primary supervisor to PhD student
- Study coordinator: Mark Griffiths, PhD FRCP
- Email: Mark.griffiths@bartshealth.nhs.uk
- Phone: 07875999126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.