Ventilation During Cardiopulmonary Bypass (CPB) for Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02070445
Recruitment Status : Suspended (One of the investigators left the institution.)
First Posted : February 25, 2014
Last Update Posted : September 7, 2017
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University

Brief Summary:

During most types of heart surgery cardiopulmonary bypass (CPB) is used. CPB enables blood to be directed away from the heart and the lungs and pumped through the body while the heart is not beating. Surgery on the heart easier when it is not beating and bloodless area. Generally during CPB the lungs do not need to be ventilated, as no blood is flowing through the lungs and the body received oxygen from a machine (oxygenator) attached to the CPB pump.

In this study we are investigating the difference in lung collapse after heart surgery in patient who did have their lungs ventilated during CPB, compared to patients who did not have their lungs ventilated during CPB. We will use lung ultrasound scans to determine the degree of lung collapse at various time periods before and after the heart surgery. We will also investigate if ventilation during CPB will affect: a.) the rate of lung infection or pneumonia after the operation b.) the time it takes for a patient to have the breathing tube removed in the intensive care unit after the operation c.) the time for a patient to be discharged home from the hospital d.) the concentration of oxygen in the blood after the operation.

Condition or disease
Pulmonary Atelectasis

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ventilation During Cardiopulmonary Bypass (CPB) for Cardiac Surgery - Effect on Pulmonary Atelectasis Post-operatively, a Pilot Study
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

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U.S. FDA Resources

Patients undergoing CABG
Patients will have no ventilation during CABG. There will be non-invasive assessments of the lung using ultrasound at different times during the perioperative period.The first assessment will be conducted before anesthesia induction (i.e. patients will be awake). A second assessment will be conducted after anesthesiology induction, but before the beginning of surgery. A third assessment will be conducted at the end of the surgery in the operating room. And two subsequent assessments will be conducted in ICU before and after extubation.

Primary Outcome Measures :
  1. Feasibility [ Time Frame: 3 months ]
    To assess feasibility of LUS investigation in pre-operative and post-operative patients (time required to complete study in operating room and ICU, practicality of performing LUS in a busy environment). The LUS investigations are reported to be a fast and reliable investigation. However, few data are available about its use in a perioperative setting.

Secondary Outcome Measures :
  1. Assess the evolution of LUS [ Time Frame: 3 months ]
    To assess the evolution of LUS during the perioperative period. Anesthesiology induction and mechanical ventilation are recognized to induce modifications in lung ventilation and aeration. Despite this, it is unclear that LUS will be able to detect these variations. Further, the optimal timing to evaluate the LUS is not known. The optimal time for LUS assessment measurement needs to take into consideration lung ventilation parameters and also practical realization in the operating room.

  2. Determine sample size for future Randomized Control Trial [ Time Frame: 3 months ]
    To allow us to determine sample size for future randomized controlled trials. As a matter of fact, the distribution of this parameter (LUS) is not well described for perioperative patients. In order to evaluate the potential effect of lung ventilation during CPB, we first need to get an accurate estimation of LUS in the control (unventilated) population. This data will allow us to clearly define the hypothesis to test with regard to the expected treatment effect of lung ventilation during CPB.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Same Day Surgery Clinic

Inclusion Criteria:

  • Adult elective coronary artery bypass surgery requiring CPB

Exclusion Criteria:

  • Cardiac surgery without CPB
  • Complex cardiac surgery (valve repairs, combined bypass and valve repairs etc.)
  • Emergency cardiac surgery
  • Fibrotic lung disease
  • Previous lung volume reduction surgery (CXR will be assessed pre-operatively)
  • Massive blood product transfusion intra- and/or post-operatively will exclude patient
  • Patients enrolled in other studies eg. SIRS study (steroid use)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02070445

Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Principal Investigator: Summer Syed, MD McMaster University and Hamilton Health Sciences