In-Bed Cycling in ICU Patients Post Cardiac Surgery

NCT02976415 | Completed

• 1 other identifier: 2016-1999-GRA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Disease; Critical Illness; Critical Illness Polyneuropathy; Critical Illness Myopathy; Thoracic Surgery

Keywords

Cardiac Surgery; Physiotherapy; In-Bed Cycling; Mechanical Ventilation; Cycle Ergometry; Early Mobilization; Rehabilitation; Critical Care; Intensive Care Unit

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Feasibility of Completing Hand Grip Strength at ICU Awakening and ICU Discharge

  When patient awake (unspecified time, patient dependent), at completion of study involvement (maximum: day 28 of ICU)

• Two Minute Walk Test

  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)

  Assessed daily, up to a maximum of 28 days

Interventions

In-Bed Cycling OTHER

20 minutes of in-bed cycling, either active, passive or a combination of active and passive.

Also known as: Bedside Cycling, Bedside Ergometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton General Hosptial

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

• 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.

  PMID: 33407923 DERIVED

MeSH Terms

Conditions

Heart Diseases; Critical Illness; Polyneuropathies

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Anastasia N Newman, PhD Student

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD Student

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 29, 2016
• Study Start: August 28, 2017
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)