GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis

NCT ID: NCT04253834

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-27
• Study Completion Date: 2021-01-31

Brief Summary

This study compares a novel breathing device, called the GO2 Mouthpiece, to the standard breathing tool called the incentive spirometer, thus improving respiratory dynamics of the postoperative patient.

Detailed Description

Postoperative pulmonary complications (PPCs) are the principal cause of morbidity, mortality and prolonged hospitalizations in surgical patients, which results in a 50% increase in healthcare costs compared to postoperative cardiac complications. This is especially evident following cardiovascular surgery. One of the most common PPCs is atelectasis, resulting in dyspnea, tachypnea and hypoxemia.

Postoperative atelectasis is a predictable consequence of anesthesia, surgical trauma, and pain associated with breathing. Methods aimed at increasing lung volume and treating atelectasis, commonly known as postoperative physiotherapy, play an important role in preventing PPCs. These methods include cough and deep breathing, continuous positive airway pressure (CPAP), postural drainage, incentive spirometry and positive end expiratory pressure (PEEP).

Incentive spirometry has served as a convenient approach for the postoperative patient to sustain maximal inflations and encourage deep breathing. Although incentive spirometry is used commonly by post-operative patients, evidence fails to support its benefit.

PEEP is a well-known pulmonary physiologic principle. There are on average 600 million alveoli in the lung. Each alveolus has surfactant to resist the natural propensity for these small air sacs to collapse during exhalation. Despite this surfactant, some alveoli will collapse and not be available for gas exchange. This atelectasis results in a ventilation/perfusion mismatch where alveolar units are perfused but not adequately ventilated. This is referred to as shunting and results in hypoxemia (decreased PaO2). PEEP decreases the propensity for the alveoli to collapse by increasing the air pressure in the lungs. This residual pressure in the lungs at the end of exhalation decreases shunting and allows for more complete gas exchange and improved oxygenation. In patients, PEEP is one of the safest ways to increase PaO2 and is used on almost all modern ventilator settings.

The purpose of this study is to compare a novel breathing device, called the GO2 Mouthpiece, which uses the concept of PEEP, to the incentive spirometer in postoperative patients.

Conditions

Postoperative Atelectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Incentive Spirometer Control Arm

Participants assigned to use the incentive spirometer after surgery.

Group Type: ACTIVE_COMPARATOR

Incentive spirometer

Intervention Type: DEVICE

The incentive spirometer is a device that measures how deeply a person can inhale (breathe in). It helps with taking slow, deep breaths to expand and fill the lungs with air, which helps prevent lung problems, such as pneumonia. The incentive spirometer is made up of a breathing tube, an air chamber, and an indicator to help users control their breathing.

GO2 Mouthpiece

Participants assigned to use the Bidirectional Oxygenation Valve (GO2 Mouthpiece) after surgery.

Group Type: EXPERIMENTAL

GO2 Mouthpiece

Intervention Type: DEVICE

The GO2 Mouthpiece is a simple, comfortable, and straightforward silicone rubber-made, bidirectional oxygenation mouthpiece that effectively delivers PEEP with every breath.

Interventions

Incentive spirometer

The incentive spirometer is a device that measures how deeply a person can inhale (breathe in). It helps with taking slow, deep breaths to expand and fill the lungs with air, which helps prevent lung problems, such as pneumonia. The incentive spirometer is made up of a breathing tube, an air chamber, and an indicator to help users control their breathing.

Intervention Type: DEVICE

GO2 Mouthpiece

The GO2 Mouthpiece is a simple, comfortable, and straightforward silicone rubber-made, bidirectional oxygenation mouthpiece that effectively delivers PEEP with every breath.

Intervention Type: DEVICE

Other Intervention Names

Bidirectional Oxygenation Valve

Eligibility Criteria

Inclusion Criteria

1. Undergoing coronary artery bypass surgery (CABG) and/or valve replacement surgery

2. Able to provide written informed consent

3. Maintenance of an arterial line postoperatively

Exclusion Criteria

1. Active smoking, within three months of surgery

2. Forced expiratory volume in one second (FEV1) <75% predicted

3. Relative risk to develop pulmonary barotrauma as evident by history of pneumothorax or emphysema

4. Unable or unwilling to provide informed consent, cognitive impairment

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PEEP Medical, LLC

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Miller

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00117254

Identifier Type: -

Identifier Source: org_study_id