Critical Illness
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIn-bed cycling
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.
OTHERUsual Care
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.
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. age ≥ 3 years to \< 18 years; 2. Limited to bed-rest or bed mobility at time of screening 3. expected PICU stay for an additional 48 hours minimum, at time of screening 4. informed consent and or assent where appropriate; 5. agreement of the most responsible PICU physician.
Exclusion criteria
1. Contraindications: e.g. Hemodynamic instability, unstable or uncontrolled arrhythmia, ICP, unstable airway, unstable fractures/spine 2. Contraindication to mobilizing upper/lower limbs, e.g. femoral sheath 3. Cycle ergometer does not fit body dimensions 4. Already mobilizing well/expected to mobilize out of bed within 24h 5. not expected to survive current admission - i.e. predicted hospital mortality of \> 90%;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - enrolment (75% consent rate target) and protocol adherence | 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 7 days | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Organ Dysfunction severity as measured by PELOD-2 | 30 days | organ dysfunction severity progression will be measured by the Pediatric Logistic Organ Dysfunction score (PELOD-2) |
| PCCU-acquired morbidities | 30 days | Incidence of PCCU-acquired weakness, pressure ulcers, delirium, sedation withdrawal and delirium |
| Mortality | 6 months | PCCU, hospital, 3 and 6 month mortality |
| Functional outcome (functional recovery, as measured by the Pediatric Overall Performance (POPC), the Pediatric Cerebral Performance Category (PCPC) Scores, and the Pediatric Disability Inventory) | PCCU discharge, 3 and 6 months post PCCU discharge | 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) |
| Length of stay | 30 days | The length of Paediatric intensive care unit and hospital stay, will be measured |
| Caregiver perception | 7 days | Caregiver impressions of early mobilization interventions, and barriers and facilitators to early mobilization in critically ill children |
| Duration of Mechanical Ventilatory support | 30 days | The number of days on mechanical ventilatory support, and the number of days alive and free of mechanical ventilatory support at 30 days |
| Workload (physiotherapist and nursing workload, as measured by set up and take down times) | 7 days | We will assess the physiotherapist and nursing workload in both groups |
Countries
Canada
Outcome results
None listed