Critical Illness Clinical Trial
— wEECycleOfficial title:
Early Exercise in Critically Ill Youth and Children, a preLiminary Evaluation.
Verified date | August 2018 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 17 Years |
Eligibility |
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%; |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster Children's Hospital | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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) | PCCU discharge, 3 and 6 months post PCCU discharge | |
Other | 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 | |
Other | 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 | |
Other | PCCU-acquired morbidities | Incidence of PCCU-acquired weakness, pressure ulcers, delirium, sedation withdrawal and delirium | 30 days | |
Other | Mortality | PCCU, hospital, 3 and 6 month mortality | 6 months | |
Other | 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 | |
Other | Length of stay | The length of Paediatric intensive care unit and hospital stay, will be measured | 30 days | |
Other | Caregiver perception | Caregiver impressions of early mobilization interventions, and barriers and facilitators to early mobilization in critically ill children | 7 days | |
Primary | 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 | |
Secondary | 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 |
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