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

Royal College of Surgeons, Ireland

Status

Suspended

Conditions

Critical Illness

Critical Illness Myopathy

Treatments

Other: Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle training

Study type

Interventional

Funder types

Other

Identifiers

NCT07055789

4331

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.