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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Raul Mendoza-Ayala, Aurora BayCare Medical Center
ClinicalTrials.gov Identifier:
NCT01522222
First received: January 24, 2012
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Heart Failure
Procedure: continuous, mechanical ventilatory support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Continuous Mechanical Ventilation During Cardiopulmonary Bypass on The Lung Mechanics: A Prospective Evaluation

Resource links provided by NLM:


Further study details as provided by Aurora BayCare Medical Center:

Primary Outcome Measures:
  • Post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis. [ Time Frame: During in-patient stay ] [ Designated as safety issue: No ]
    Determination if ventilation during surgery improves post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
half of the study subjects will receive standard of care during their open heart surgery.
Experimental: Treatment
half of the study subjects will receive the prescribed ventilatory support during open heart surgery.
Procedure: continuous, mechanical ventilatory support
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01522222

Locations
United States, Wisconsin
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Sponsors and Collaborators
Aurora BayCare Medical Center
Investigators
Principal Investigator: Raul Mendoza-Ayala, MD Aurora Health Care
  More Information

No publications provided

Responsible Party: Raul Mendoza-Ayala, Pulmonologist, Aurora BayCare Medical Center
ClinicalTrials.gov Identifier: NCT01522222     History of Changes
Other Study ID Numbers: PEEP
Study First Received: January 24, 2012
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Aurora BayCare Medical Center:
cardiopulmonary bypass surgery
CABG
PEEP

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014