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

CardiO Cycle: A Pilot Safety and Feasibility Study of In-Bed Cycling in Patients Post Cardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Critical Illness Myopathy; Thoracic Surgery; Cardiac Disease; Critical Illness Polyneuropathy
• Intervention / Treatment: Other: In-Bed Cycling

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of safety events that occur during cycling sessions	Potential safety events include: Hypertension (systolic blood pressure greater than 160 mmHg); Hypotension (systolic blood pressure less than 90 mmHg); Oxygen desaturation to less than 85% for more than two minutes; Cardiorespiratory arrest; Removal of any lines or tubes (chest tubes, pulmonary artery catheter, nasal-gastric tube, Jackson-Pratt drains, central venous catheter, endotracheal tube, tracheostomy decannulation); New onset cardiac arrhythmias (atrial fibrillation, bigeminy, trigeminy, junctional, heart block rhythms); Saphenous vein graft dehiscence; New onset agitation	From date of study enrollment until the date of study completion, up to 28 days maximum
Feasibility of completing 80% of eligible cycling sessions	The feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least 80% of the time that cycling is appropriate.	From date of study enrollment to the date of study completion, up to 28 days maximum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Completing Hand Grip Strength at ICU Awakening and ICU Discharge	Hand grip strength will be assessed using a hand-held JAMAR dynamometer. Patients will be seated with elbow bent to 90 degrees. Patients will be asked to "squeeze the handle as hard as possible" and the maximum score will be taken after five seconds. Average of three trials will be documented.	When patient awake (unspecified time, patient dependent), at completion of study involvement (maximum: day 28 of ICU)
Two Minute Walk Test	In an unobstructed area, patients will be instructed to walk back and forth covering as much distance as possible in two minutes. Gait aids may be used and patients are permitted to rest as needed during the test. No encouragement will be provided during the two minute test. The number of rest stops, the duration of the rests and the distance traveled in meters will be documented.	At ICU Awakening (an estimated 8 days after study enrollment) and at the completion of the study (maximum: day 28 of ICU)
Functional Status Score for the ICU (FSS-ICU)	The FSS-ICU is a five-item functional measure that evaluates the ability of each client to perform five specific tasks (rolling, supine to sit, sitting at edge of bed, sit to stand, walking). Each scale is assessed using an 8-point ordinal scale (0 - inability to perform the task to 7 - able to perform the task independently)	Assessed daily, up to a maximum of 28 days

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Anastasia N Newman, PhD Student, Hamilton Health Sciences Corporation

Publications and helpful links

General Publications

• Newman ANL, Kho ME, Harris JE, Zamir N, McDonald E, Fox-Robichaud A, Solomon P; Canadian Critical Care Trials Group. CardiO Cycle: a pilot feasibility study of in-bed cycling in critically ill patients post cardiac surgery. Pilot Feasibility Stud. 2021 Jan 7;7(1):13. doi: 10.1186/s40814-020-00760-5.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Actual): March 29, 2019
• Study Completion (Actual): March 29, 2019

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Intensive Care Unit; Cardiac Surgery; Physiotherapy; Mechanical Ventilation; Cycle Ergometry; Critical Care; Early Mobilization; In-Bed Cycling
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Nervous System Diseases; Disease Attributes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Heart Diseases; Critical Illness; Polyneuropathies
• Other Study ID Numbers: 2016-1999-GRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No