CompletedNot Applicable

Is Combined Respiratory Muscle Training, Incorporating Inspiratory and Expiratory Training, Feasible in Adult Critical-care Patients?

Ireland22 participantsStarted 2024-10-01

Plain-language summary

Background: Respiratory muscle weakness is a recognised consequence of mechanical ventilation in critical care. This weakness can have implications for patients, leading to prolonged mechanical ventilation (MV) and intensive care unit (ICU) length of stay (LOS), with worse mortality and morbidity outcomes. The aim of this trial is to assess the safety and feasibility of a combined respiratory muscle training (RMST) intervention for respiratory muscle strengthening, in adult critical care patients receiving or recently liberated from mechanical ventilation. Methods: This prospective single-arm feasibility study will be conducted in Tallaght University Hospital (TUH) ICU. Ethical approval will be sought from TUH ethics committee with sponsorship from (RCSI) Royal College of Surgeons Ireland. Informed consent will be sought from all eligible patients. Participants will receive a combined RMST intervention in addition to usual care. The primary feasibility outcomes of recruitment, adherence and retention will be reported. Secondary clinical outcomes of respiratory muscle strength (maximal inspiratory / expiratory pressure) and cough strength (peak cough flow) will be assessed at recruitment and weekly up to week three. Therapist perception of service usability will be assessed using the service usability survey.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients ≥18years, * mechanically ventilated for ≥ 24 hours, * able to initiate spontaneous breaths on MV, * on suitable levels of respiratory support with ≤.6 FiO2, ≤10 PEEP, * deemed eligible for MV weaning by ICU consultant or recently extubated (\<48 hours), * alert and collaborative (RASS -2 to +2). Exclusion Criteria: * patients deemed medically unfit by the ICU physicians * pregnant patients or breast feeding patients * patients with specific pathologies that may impair respiratory muscle function and response to interventions independent of mechanical ventilation and critical care stay * Patient who have undergone surgical intervention / repair of the diaphragm within 6 months of the trial, diaphragm / hemi-diaphragm paralysis, * patients unable to consent / collaborate in treatment, * patients may also be excluded if the ICU physician deems the short disconnection period from MV is unsuitable, * patients for palliative management or unlikely to survive their critical care episode.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment Rate Retention and Adherence Rates

Timeframe: Up to 2 years

Retention Rates

Timeframe: Up to 2 years

Adherence Rates

Timeframe: Up to 2 years

Trial details

NCT IDNCT07055789

SponsorRoyal College of Surgeons, Ireland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-28

View on ClinicalTrials.gov More Critical Illness Myopathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.