In-Bed Cycling in ICU Patients Post Cardiac Surgery (CardiO Cycle)

Hamilton Health Sciences (HHS)

Status

Completed

Conditions

Cardiac Disease

Critical Illness

Critical Illness Polyneuropathy

Critical Illness Myopathy

Thoracic Surgery

Treatments

Other: In-Bed Cycling

Study type

Interventional

Funder types

Other

Identifiers

NCT02976415

2016-1999-GRA

Details and patient eligibility

About

The purpose of this study is to determine if in-bed cycling is safe and feasible in critically-ill patients after open heart surgery. The investigators hypothesize that in-bed cycling can be safely used with this population and that it is feasible to use in a fast-paced cardiac intensive care unit.

Full description

Background: Advances in medical science and technologies have lead to more effective management of critically-ill patients with a subsequent improvement in ICU survival rates. Patients who survive their ICU stay are often left with post-ICU impairments including muscle weakness and functional limitations. Cardiac surgeries are commonly performed worldwide with the majority of patients requiring post-operative ICU care. In the past decade, patients who qualify for cardiac surgery tend to be older, have a great number of co-morbidities and are more likely to require a prolonged ICU stay. The effectiveness of physiotherapy and various rehabilitation modalities in patients both pre- and post cardiac surgery has been investigated. However, to date no study specifically addresses the feasibility and safety of in-bed cycling in patients undergoing cardiac surgery who require prolonged critical care.

Principle Research Question: Is in-bed cycling a safe and feasible intervention in patients post cardiac surgery that require a prolonged stay in critical care?

Methods: Adult patients post-cardiac surgery admitted to the cardiac surgery ICU who will remain intubated and ventilated for at least 72 hours will be eligible for enrollment. Participants will receive 20 minutes of in-bed cycling plus routine physiotherapy performed by critical care physiotherapists. Patients will be enrolled for 28 days or until they are able to ambulate.

Primary Outcomes: Safety of bedside cycling will be evaluated by monitoring the number of adverse events that occur during each cycling session. Feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least eighty percent of the time that cycling is appropriate.

Relevance: Before conducting a larger randomized controlled trial investigating the effectiveness of in-bed cycling in the critically-ill cardiac surgery population, the safety of this intervention needs to be determined. This will be the first study in a program of research evaluating bedside cycling in the cardiac surgical ICU.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female adults patients aged 18 years and greater
History of cardiac surgery in the past seven days
Admitted to the cardiac surgery ICU for greater than 3 days but less than 7 days
Mechanically ventilated for at least 72 hours and expected to remain ventilated for at least two more days
Able to ambulate independently, with or without a gait aid, prior to hospital admission

Exclusion criteria

Uncomplicated post-operative course with expected discharge to ward within 24 to 72 hours
Previous lower extremity amputation
Open or unstable saphenous vein graft sites
Inability to understand English
Body size and/or weight that is incompatible with the bedside ergometer
Patients who are not expected to survive their ICU stay