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Early Rehabilitation in Critically Ill Children Pilot Study (WeeHab in PCCU)

Primary Purpose

Critical Illness

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Early Rehabilitation intervention
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Pediatrics,, Critically ill Children, immobility

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Anticipated PCCU stay of more than 24 hours.
  2. Clinical stable children at PCCU
  3. Informed consent and or assent where appropriate
  4. Agreement of the most responsible PCCU physician
  5. Age ≥ 3years to < 18 years

Exclusion Criteria:

  1. Hemodynamic instability, defined as requiring escalation in vasoactive agents or volume resuscitation within the preceding 4 hours. (Patients who are on stable or weaning doses of vasoactive agents will be considered eligible).
  2. Anticipated death and/ or withholding of life-sustaining therapies
  3. The presence of a contraindication to mobilization- e.g. Suspected or actual evidence of cerebral edema or elevated ICP, unstable spinal cord injuries, musculoskeletal injuries/ fixed deformities in the lower limbs (for the use of cycle ergometer) or the upper limbs (for the use of interactive video-gaming)
  4. Unstable airway (defined as impending respiratory failure and/or endotracheal intubation is anticipated within the next 4 hours).
  5. Patients who are already mobilizing well/or at their baseline level of function

Sites / Locations

  • McMaster Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm: Study Intervention

Arm Description

Cycle ergometry and/or Interactive video-game

Outcomes

Primary Outcome Measures

Feasibility
The primary outcome of interest in this pilot study is feasibility. Feasibility is defined as follows: The ability to screen and enroll eligible patients - enrolment rate of at least 70% of those approached for consent (benchmark for PCCU trials) Time to application of acute rehabilitation intervention. Protocol adherence - a protocol violation rate of < 10%.

Secondary Outcome Measures

Safety
The proportion of patients with adverse events attributable to the rehabilitation intervention (e.g. cardiorespiratory events, tube dislodgement's).
Change in activity from baseline
Change in activity from baseline, during and following the intervention as measured by accelerometer, and patient
Caregiver/user perception of intervention
Self-administered survey of caregiver and or user, to evaluate perceptions of intervention

Full Information

First Posted
February 7, 2012
Last Updated
November 4, 2013
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT01531816
Brief Title
Early Rehabilitation in Critically Ill Children Pilot Study
Acronym
WeeHab in PCCU
Official Title
Early Rehabilitation in Critically Ill Children, a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Critically ill patients are often confined to bedrest, because of the nature of their illness. However, it has now been shown that prolonged bedrest and immobility, particularly in critically ill adults and children, can lead to serious outcomes such as muscle weakness and prolonged stay in the intensive care unit (ICU). Research in adults has demonstrated that preventing immobility and introducing exercise and rehabilitation in adult patients early during their ICU illness can prevent these serious outcomes, reduce the duration of hospital stay, and enhance their recovery after they leave the ICU. The purpose of our research is to investigate if early mobilization and rehabilitation can also be performed in critically ill children, and eventually evaluate this results in beneficial outcomes in these children, as it has been shown to be in adults. However, given that children are not the same as adults, but have varying abilities to understand and participate in activities when they are sick, the investigators first have to evaluate the most appropriate and safe ways of helping children "exercise" while they are in the ICU. This objective of this study is to evaluate if 2 methods of rehabilitation (a stationary bike and interactive video game) can be implemented in critically ill children. These methods have been used in hospitalized children and in critically ill adults. The investigators will evaluate if these methods are safe for critically ill children.
Detailed Description
In this prospective cohort pilot study, eligible critically ill children aged 3 to 17 years will receive in addition to their usual care, a passive and/or an active mobility intervention, depending on their level of consciousness or cognitive ability. The active intervention will consist of an interactive video game (X Box 360 Kinect), while a cycle ergometer will be used as the passive intervention. The mobility interventions will be applied for a minimum of 10 minutes on day 1, and 20 minutes on day 2. For unconscious patients, or eligible patients who cognitively impaired, the passive intervention will be applied. As soon as the patient is conscious and cooperative, the active intervention will be applied. The primary outcomes of interest in this pilot study are feasibility (defined as the ability to screen and enroll patients, consent rate and protocol adherence). Secondary outcomes of interest include safety outcomes, clinical outcomes and patient and caregiver satisfaction with the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Pediatrics,, Critically ill Children, immobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm: Study Intervention
Arm Type
Experimental
Arm Description
Cycle ergometry and/or Interactive video-game
Intervention Type
Device
Intervention Name(s)
Early Rehabilitation intervention
Other Intervention Name(s)
Cycle Ergometer, X Box 360 Kinect
Intervention Description
Passive mobility: cycle ergometer Active mobility: interactive video-game (X Box 360 Kinect) Each intervention will be applied for a maximum of 2 days respectively. If a participant is unconscious on Day 1 and receives the passive intervention, and thereafter becomes alert and cooperative on day 2, then he/she can receive the active intervention.
Primary Outcome Measure Information:
Title
Feasibility
Description
The primary outcome of interest in this pilot study is feasibility. Feasibility is defined as follows: The ability to screen and enroll eligible patients - enrolment rate of at least 70% of those approached for consent (benchmark for PCCU trials) Time to application of acute rehabilitation intervention. Protocol adherence - a protocol violation rate of < 10%.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Safety
Description
The proportion of patients with adverse events attributable to the rehabilitation intervention (e.g. cardiorespiratory events, tube dislodgement's).
Time Frame
Study period
Title
Change in activity from baseline
Description
Change in activity from baseline, during and following the intervention as measured by accelerometer, and patient
Time Frame
From baseline to end of intervention
Title
Caregiver/user perception of intervention
Description
Self-administered survey of caregiver and or user, to evaluate perceptions of intervention
Time Frame
At end of study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anticipated PCCU stay of more than 24 hours. Clinical stable children at PCCU Informed consent and or assent where appropriate Agreement of the most responsible PCCU physician Age ≥ 3years to < 18 years Exclusion Criteria: Hemodynamic instability, defined as requiring escalation in vasoactive agents or volume resuscitation within the preceding 4 hours. (Patients who are on stable or weaning doses of vasoactive agents will be considered eligible). Anticipated death and/ or withholding of life-sustaining therapies The presence of a contraindication to mobilization- e.g. Suspected or actual evidence of cerebral edema or elevated ICP, unstable spinal cord injuries, musculoskeletal injuries/ fixed deformities in the lower limbs (for the use of cycle ergometer) or the upper limbs (for the use of interactive video-gaming) Unstable airway (defined as impending respiratory failure and/or endotracheal intubation is anticipated within the next 4 hours). Patients who are already mobilizing well/or at their baseline level of function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Choong, MB, BCh, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

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Early Rehabilitation in Critically Ill Children Pilot Study

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