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To evaluate the feasibility of conducting a randomized controlled trial (RCT) evaluating the efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children.
This is a single centre, Pilot RCT that will evaluate in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children. We will conduct a qualitative substudy to evaluate caregiver impressions of the intervention, and to understand barriers and facilitators to implementing early mobilization in critically ill children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycle ergometry | Experimental | Participants will receive In-bed cycling for 30 minutes per day in addition to Usual Care, until the physiotherapist deems that the patient is mobilizing well, or a maximum of 7 days (whichever comes first). |
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| Usual care | Active Comparator | Usual care physiotherapy will be applied to patients in the control arm, according to the unit specific guidelines for early mobilization |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-bed cycling | Device | In-bed cycling will be applied using a cycle ergometer (RT300 Supine Cycle Ergometer) for 30 minutes per day in addition to Usual Care, until the physiotherapist deems that the patient is mobilizing well, or a maximum of 7 days (whichever comes first). This cycle ergometer is specifically designed for pediatric use, and can be applied to facilitate lower or upper limb cycling. The intervention will be applied by a trained physiotherapist and/or clinician. Pre-defined Safety Criteria for interrupting or aborting the intervention will be observed. Qualitative interviews will be conducted with a health care provider, the patient where possible, and a family caregiver following the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - enrolment (75% consent rate target) and protocol adherence | Feasibility is defined as the ability to screen and enrol eligible patients (75% consent rate target).Protocol adherence will be defined as the ability to apply in-bed cycling intervention within 24 hours of consent, and the ability to apply 30 minutes of in-bed cycling daily during week days. We will also measure the rates and reasons for protocol suspensions, violations and study withdrawal. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | Adverse event rates, physiological parameters prior to, during and after the intervention, discomfort or pain related to the study intervention (as measured by validated pediatric scores). | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome (functional recovery, as measured by the Pediatric Overall Performance (POPC), the Pediatric Cerebral Performance Category (PCPC) Scores, and the Pediatric Disability Inventory) | We will assess functional recovery at 3 and 6 months (as measured by the Pediatric Overall Performance (POPC), the Pediatric Cerebral Performance Category (PCPC) Scores, and the Pediatric Disability Inventory) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Choong, MB, BCh, MSc | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Children's Hospital | Hamilton | Ontario | L8S 4K1 | Canada |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Usual Care | Other | Usual care physiotherapy will be applied to patients in the control arm, according to the unit specific guidelines for early mobilization. Qualitative interviews will be conducted with a health care provider, the patient where possible, and a family caregiver following the intervention period. |
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| PCCU discharge, 3 and 6 months post PCCU discharge |
| Workload (physiotherapist and nursing workload, as measured by set up and take down times) | We will assess the physiotherapist and nursing workload in both groups | 7 days |
| Organ Dysfunction severity as measured by PELOD-2 | organ dysfunction severity progression will be measured by the Pediatric Logistic Organ Dysfunction score (PELOD-2) | 30 days |
| PCCU-acquired morbidities | Incidence of PCCU-acquired weakness, pressure ulcers, delirium, sedation withdrawal and delirium | 30 days |
| Mortality | PCCU, hospital, 3 and 6 month mortality | 6 months |
| Duration of Mechanical Ventilatory support | The number of days on mechanical ventilatory support, and the number of days alive and free of mechanical ventilatory support at 30 days | 30 days |
| Length of stay | The length of Paediatric intensive care unit and hospital stay, will be measured | 30 days |
| Caregiver perception | Caregiver impressions of early mobilization interventions, and barriers and facilitators to early mobilization in critically ill children | 7 days |