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NCT03471247 · ClinicalTrials.gov registry record · NA
CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
A NA study of Respiratory Failure and Mechanical Ventilation, sponsored by McMaster University.
- Active
- Registry status
- NA
- Development phase
- 360
- Enrollment target
- 16
- Study locations
NCT03471247: Active NA study of Respiratory Failure and Mechanical Ventilation, sponsored by McMaster University.
NCT03471247 is a NA study of Respiratory Failure and Mechanical Ventilation that is active but no longer recruiting, run by McMaster University. The registered enrollment target is 360 participants, below the 4,515-participant average among 40 other Respiratory Failure trials with a reported enrollment target (92% lower). The trial reports 16 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03471247, a NA study of Respiratory Failure and Mechanical Ventilation, is active but no longer recruiting, sponsored by McMaster University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 360 participants
- Enrollment target
- 16
- Study locations
Study 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 this morbidity. In-bed cycling, which uses a special bicycle that attaches to the hospital bed, allows critically ill patients who are mechanically ventilated (MV) to gently exercise their legs while in the ICU. The main goal of this study is to determine whether critically ill MV adults recover faster if they receive early in-bed cycling than if they do not. Another objective is to determine whether in-bed cycling is a cost-effective intervention. 360 patients admitted to the ICU and receiving MV will be enrolled in the study. Following informed consent, patients will be randomized to either (1) early in-bed cycling and routine physiotherapy or (2) routine physiotherapy alone. Patients' strength and physical function will be measured throughout the study. If early in-bed cycling during critical illness improves short-term physical and functional outcomes, it could accelerate recovery and reduce long-term disability in ICU survivors.
Conditions Studied
Interventions
- DEVICE In-Bed Cycle Ergometer
- OTHER Routine PT
Study Locations (16)
Ontario
- Brant Community Healthcare System - Brantford General Hospital - Brantford
- Hamilton Health Sciences - Hamilton General Hospital - Hamilton
- St. Joseph's Healthcare Hamilton - Hamilton
- Hamilton Health Sciences - Juravinski Hospital - Hamilton
- Kingston Health Sciences Centre - Kingston General Hospital - Kingston
- London Health Sciences Centre - Victoria Hospital - London
- The Ottawa Hospital - General Campus - Ottawa
- The Ottawa Hospital - Civic Campus - Ottawa
- Niagara Health System - St. Catharines Site - St. Catharines
- St. Michael's Hospital - Toronto
Quebec
- Centre Integre de Sante et de Services Sociaux de Chaudiere-Appalaches - Hotel-Dieu de Levis - Lévis
- Centre Integre Universitaire de Sante et de Services Sociaux du Nord-de-L'Ile-de-Montreal - Hopital du Sacre-Coeur de Montreal - Montreal
- Centre Integre Universitaire de Sante et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke - Sherbrooke
Maryland
- University of Maryland Medical Centre - Baltimore
North Carolina
- Duke University Hospital - Durham
Victoria
- Austin Health - Austin Hospital - Heidelberg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2018-10-15 |
| Est. Completion | 2024-08 |
| Phase | NA |
What the registry record for NCT03471247 still lists
NCT03471247 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 4,515-participant average among 40 other Respiratory Failure trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Respiratory Failure appearing as the primary indexed condition, and to 2 interventions - of which In-Bed Cycle Ergometer is the first listed.
NCT03471247 lists 16 locations in 5 states (Ontario, Quebec, Maryland).
Frequently Asked Questions
What is clinical trial NCT03471247 about?
NCT03471247 is a clinical study titled "CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients". 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 this morbidity. In-bed cycling, which uses a special bicycle that attaches to the hospital bed, allow...
What is the current status of trial NCT03471247?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2018-10-15. Estimated completion is 2024-08.
What conditions does trial NCT03471247 study?
This clinical trial studies the following conditions: Respiratory Failure, Mechanical Ventilation, Critical Care, Intensive Care Unit Acquired Weakness.
What interventions are being tested in trial NCT03471247?
The interventions under investigation include: In-Bed Cycle Ergometer (DEVICE), Routine PT (OTHER).
Who is sponsoring clinical trial NCT03471247?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03471247 being conducted?
This trial has 16 study locations across Maryland, North Carolina, Victoria, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03471247's enrollment target sits among peer trials
360 13th of 40 higher than 28 of 40 other Respiratory Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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