Early In-bed Cycling in Critically Ill Children

McMaster University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Illness

Interventions

In-bed cyclingDEVICE

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.

Usual CareOTHER

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

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%;

Locations (1)

McMaster Children's Hospital

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 7 days

Secondary Outcomes

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).

Time frame: 7 days

Data from ClinicalTrials.gov

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