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 range18 Years

SexALL

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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.

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 range18 Years

SexALL

See this in plain English?

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