Ventilation During Cardiopulmonary Bypass (CPB) for Cardiac Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by McMaster University
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT02070445
First received: February 21, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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
Pulmonary Atelectasis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Assess the evolution of LUS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Determine sample size for future Randomized Control Trial [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Same Day Surgery Clinic

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070445

Contacts
Contact: Summer Syed, MD 905-521-2100 ext 46698 syeds@mcmaster.ca
Contact: Simone Schulein, MD 905-521-2100 ext 46698 simone.s@doctors.org.uk

Locations
Canada, Ontario
Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Geoff Travis    905-521-2100 ext 44746    travisg@mcmaster.ca   
Contact: Toni Tidy, HBSc, CCRA    905-525-9140 ext 21737    tonitidy@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Summer Syed, MD McMaster University and Hamilton Health Sciences
  More Information

Publications:
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02070445     History of Changes
Other Study ID Numbers: 13-859
Study First Received: February 21, 2014
Last Updated: February 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
CABG
pilot
ultrasound
perioperative
low tidal volume ventilation

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014