Status:
ACTIVE_NOT_RECRUITING
CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
Lead Sponsor:
McMaster University
Collaborating Sponsors:
St. Joseph's Healthcare Hamilton
Canadian Institutes of Health Research (CIHR)
Conditions:
Intensive Care Unit Acquired Weakness
Critical Care
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients who survive critical illness usually experience long-lasting physical and psychological impairments, which are often debilitating. Rehabilitation interventions started in the ICU may reduce t...
Detailed Description
Background: Survivors of critical illness have a long road of physical, cognitive, and psychological recovery. Although medical advances have reduced the mortality of critical illness, survival often ...
Eligibility Criteria
Inclusion
- Patient is ≥ 18 years of age
- Patient is invasively mechanically ventilated ≤ 4 days
- Expected additional 2 day ICU stay
- Ability to ambulate independently (with or without gait aid) before their critical illness
- ICU length of stay ≤ 7 days
Exclusion
- Pre-hospital inability to follow simple commands in local language at baseline
- Acute conditions impairing ability to receive cycling
- Severe cognitive impairment pre-ICU
- Traumatic brain injury
- Acute proven or suspected central or peripheral neuromuscular weakness affecting the legs (e.g., stroke, Guillian-Barre syndrome, spinal injury)
- Temporary pacemaker (internal or external)
- Expected hospital mortality ≥ 90%
- Equipment unable to fit patient's body dimensions (elg., leg amputation, morbid obesity)
- Palliative goals of care
- Pregnancy (suspected or proven)
- Specific surgical exclusion as stipulated by surgery or ICU team
- Physician declines
- Cycling exemption not resolved during first 4 days of mechanical ventilation
- Patient already able to march on spot at time of screening
Key Trial Info
Start Date :
October 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03471247
Start Date
October 15 2018
End Date
August 1 2024
Last Update
May 3 2024
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland Medical Centre
Baltimore, Maryland, United States, 21201
2
Duke University Hospital
Durham, North Carolina, United States, 27710
3
Austin Health - Austin Hospital
Heidelberg, Victoria, Australia, 3084
4
Brant Community Healthcare System - Brantford General Hospital
Brantford, Ontario, Canada, N3R 1G9