Critical Illness, Critical Illness Myopathy
Conditions
Keywords
inspiratory muscle training, expiratory muscle strength training, respiratory muscle training
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.
Interventions
OTHERCombined 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.
Sponsors
Royal College of Surgeons, Ireland
Tallaght University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single arm feasibility design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate Retention and Adherence Rates | Up to 2 years | The primary outcome measure for this trial are feasibility outcomes: Recruitment rate will be calculated by dividing the number recruited by total number of eligible patients identified and multiplying by 100. |
| Retention Rates | Up to 2 years | Retention rate will be described as the percentage of patients with follow up data available |
| Adherence Rates | Up to 2 years | Adherence rate will be measured as the number of total treatment sessions divided by the number of potential total sessions, multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Service Usability Scale. | Up to 2 years | Staff acceptability of delivering the intervention will assessed using the service usability scale. The scale assess's ten domains of service usability with a score of 1 to 5 denoting strong disagreement (1) up to strong agreement (5) |
| Inspiratory Muscle Strength | Up to 2 years | Inspiratory muscle strength will be assessed using Maximal Inspiratory Pressure (MIP): Clinical variability in maximal inspiratory pressure in response to intervention. This will be measured in cmH2O |
| Expiratory Muscle Strength | Up to 2 years | Expiratory muscle strength will be assessed using Maximal Expiratory Pressure (MEP). Clinical variability in clinical markers of maximal expiratory pressure in response to intervention. This will be measured in cmH2O |
| Cough strength | Up to 2 years | Peak Cough Flow (PCF) will be used to assess cough strength: Clinical variability in peak cough flow will be measured in response to intervention. This measurement unit is L/min. |
Countries
Ireland
Contacts
PRINCIPAL_INVESTIGATOREimear McCormack
Tallaght University Hospital & Royal College of Surgeons Ireland
PRINCIPAL_INVESTIGATORYvelynne Kelly, Doctor
Tallaght University Hospital
Outcome results
None listed