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

NCT ID: NCT01522222

Last Updated: 2018-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-09-29

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.

Conditions

Coronary Artery Disease; Heart Failure

Keywords

cardiopulmonary bypass surgery; CABG; PEEP

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

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

Group Type: EXPERIMENTAL

continuous, mechanical ventilatory support

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aurora BayCare Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Raul Mendoza-Ayala

Pulmonologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raul Mendoza-Ayala, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Countries

United States

Other Identifiers

PEEP

Identifier Type: -

Identifier Source: org_study_id