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Study to Determine if Using Ventilation During Open Heart Surgery Improves Lung Outcomes (PEEP)

Primary Purpose

Coronary Artery Disease, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
continuous, mechanical ventilatory support
Sponsored by
Aurora BayCare Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring cardiopulmonary bypass surgery, CABG, PEEP

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • any patient of any gender, any age with known coronary artery disease that will undergo elective Coronary Artery Bypass Grafting (CABG) and will require CPB as part of his/her operative technique.

Exclusion Criteria:

  • documented ejection fraction (either by echocardiogram or by cardiac catheterization) equal to or below 20%
  • patients with cardiac valvular disease
  • patients with a spirometry measurement that demonstrates an FEV1/FVC ratio below 60%
  • patients with chronic renal failure who require dialysis or
  • those who have experienced an allergic reaction to anesthesia in the past
  • patients with a history of lung infiltrate on chest X-ray prior to surgery or a history of asthma
  • Women who are pregnant are excluded

Sites / Locations

  • Aurora BayCare Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treatment

Arm Description

half of the study subjects will receive standard of care during their open heart surgery.

half of the study subjects will receive the prescribed ventilatory support during open heart surgery.

Outcomes

Primary Outcome Measures

Post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.
Determination if ventilation during surgery improves post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2012
Last Updated
December 12, 2018
Sponsor
Aurora BayCare Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01522222
Brief Title
Study to Determine if Using Ventilation During Open Heart Surgery Improves Lung Outcomes
Acronym
PEEP
Official Title
Effect of Continuous Mechanical Ventilation During Cardiopulmonary Bypass on The Lung Mechanics: A Prospective Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 29, 2015 (Actual)
Study Completion Date
September 29, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aurora BayCare Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To demonstrate that using continuous mechanical lung ventilatory support in combination with Positive End Expiratory Pressure (PEEP)during open heart surgery will improve lung function and decrease lung complications after surgery.
Detailed Description
This is a prospective, randomized, blinded study with a control group. The study group will receive mechanical ventilatory support during CBB, which consists of a preset/predetermined tidal volume, respiratory rate, positive pressure at the end of expiration and FIO2. The control group will receive CPB without additional mechanical ventilatory support during surgery, which at present is the standard of care. The difference between the study and the control group will occur during the time the heart is arrested and the lungs, under present standard of care, are no longer ventilated. It is at this point in time that those in the study group will continue to receive ventilation, intermittent positive pressure ventilation, while their heart is arrested. The subjects will have their lungs ventilated six times per minute with a tidal volume equal to 7-10 milliliters per kilogram. This range, when combined with a consistent PEEP of 5cm of water pressure, will allow for the peak inspiratory pressure to be maintained at or below 40cm of water pressure. In addition, the FIO2 will remain consistent at the same level that was needed to maintain the pulse oximetry at 94% as well as the end-tidal CO2 at 35mmHg. The values mentioned for this study have been chosen based on not only investigator preference, but also on what is considered "minimally necessary" to prevent atelectasis. Multiple studies have been done utilizing PEEP at 5 and 10 cm of water pressure. With the exception of the potential for mechanical ventilation during the CBP, the care of the subject, regardless of the group randomized into, will be the same. We will in all other aspects continue to utilize the current standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Heart Failure
Keywords
cardiopulmonary bypass surgery, CABG, PEEP

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
half of the study subjects will receive standard of care during their open heart surgery.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
half of the study subjects will receive the prescribed ventilatory support during open heart surgery.
Intervention Type
Procedure
Intervention Name(s)
continuous, mechanical ventilatory support
Intervention Description
Those in the treatment group will receive ventilation, intermittent positive pressure ventilation, while their heart is arrested. The subjects will have their lungs ventilated six times per minute with a tidal volume equal to 7-10 milliliters per kilogram. This range, when combined with a consistent PEEP of 5cm of water pressure, will allow for the peak inspiratory pressure to be maintained at or below 40cm of water pressure. In addition, the FIO2 will remain consistent at the same level that was needed to maintain the pulse oximetry at 94% as well as the end-tidal CO2 at 35mmHg.
Primary Outcome Measure Information:
Title
Post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.
Description
Determination if ventilation during surgery improves post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.
Time Frame
During in-patient stay

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: any patient of any gender, any age with known coronary artery disease that will undergo elective Coronary Artery Bypass Grafting (CABG) and will require CPB as part of his/her operative technique. Exclusion Criteria: documented ejection fraction (either by echocardiogram or by cardiac catheterization) equal to or below 20% patients with cardiac valvular disease patients with a spirometry measurement that demonstrates an FEV1/FVC ratio below 60% patients with chronic renal failure who require dialysis or those who have experienced an allergic reaction to anesthesia in the past patients with a history of lung infiltrate on chest X-ray prior to surgery or a history of asthma Women who are pregnant are excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul Mendoza-Ayala, MD
Organizational Affiliation
Aurora Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States

12. IPD Sharing Statement

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Study to Determine if Using Ventilation During Open Heart Surgery Improves Lung Outcomes

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