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| Name | Class |
|---|---|
| Tallaght University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm feasibility of combined respiratory muscle training | Experimental | The participants will undergo a combined respiratory muscle training intervention including both inspiratory and expiratory muscle training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle training | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate Retention and Adherence Rates | 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. | Up to 2 years |
| Retention Rates | Retention rate will be described as the percentage of patients with follow up data available | Up to 2 years |
| Adherence Rates | Adherence rate will be measured as the number of total treatment sessions divided by the number of potential total sessions, multiplied by 100. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Service Usability Scale. | 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) | Up to 2 years |
| Inspiratory Muscle Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eimear McCormack | Tallaght University Hospital & Royal College of Surgeons Ireland | Principal Investigator |
| Yvelynne Kelly, Doctor | Tallaght University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallaght University Hospital | Dublin | Tallaght | D24NR0A | Ireland |
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Single arm feasibility design
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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 |
| Up to 2 years |
| Expiratory Muscle Strength | 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 | Up to 2 years |
| Cough strength | 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. | Up to 2 years |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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