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

NCT ID: NCT07055789

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Critical Illness Myopathy; Critical Illness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single arm feasibility of combined respiratory muscle training

The participants will undergo a combined respiratory muscle training intervention including both inspiratory and expiratory muscle training.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

IMT: Inspiratory Muscle Training EMST: Expiratory Muscle Strength Training RMST: Respiratory Muscle Strength Training In this trial we are combining both IMT and EMST in the intervention group.

Interventions

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

IMT: Inspiratory Muscle Training EMST: Expiratory Muscle Strength Training RMST: Respiratory Muscle Strength Training In this trial we are combining both IMT and EMST in the intervention group.

Intervention Type: OTHER

Other Intervention Names

IMT; EMST; RMST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tallaght University Hospital

OTHER

Sponsor Role: collaborator

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eimear McCormack

Role: PRINCIPAL_INVESTIGATOR

Tallaght University Hospital & Royal College of Surgeons Ireland

Yvelynne Kelly, Doctor

Role: PRINCIPAL_INVESTIGATOR

Tallaght University Hospital

Locations

Tallaght University Hospital

Dublin, Tallaght, Ireland

Countries

Ireland

Other Identifiers

4331

Identifier Type: -

Identifier Source: org_study_id