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

NCT01522222 | Completed

• 1 other identifier: PEEP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Heart Failure

Keywords

cardiopulmonary bypass surgery; CABG; PEEP

Outcome Measures

Primary Outcomes (1)

• 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.

  During in-patient stay

Study Arms (2)

Control

NO INTERVENTION

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

Treatment

EXPERIMENTAL

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

Procedure: continuous, mechanical ventilatory support

Interventions

continuous, mechanical ventilatory support 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.

Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aurora BayCare Medical Center: lead

Study Sites (1)

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Raul Mendoza-Ayala, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 31, 2012
• Study Start: July 1, 2010
• Primary Completion: September 29, 2015
• Study Completion: September 29, 2015
• Last Updated: December 14, 2018

Record last verified: 2018-12

Locations

US (1)