Early In-bed Cycling in Critically Ill Children

Critical Illness Clinical Trial

— wEECycle  

Official title:

Early Exercise in Critically Ill Youth and Children, a preLiminary Evaluation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358577
• Other study ID #: 14-530
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: August 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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%;

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• In-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.

Other:
• Usual 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.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

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