GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis

GO2 PEEP Study: The Use of a Bidirectional Oxygenation Valve in the Prevention and Management of Postoperative Atelectasis

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Atelectasis
• Intervention / Treatment: Device: Incentive spirometer; Device: GO2 Mouthpiece

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory Saint Joseph's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Incentive Spirometer Control Arm; Participants assigned to use the incentive spirometer after surgery.	Device: 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.
Experimental: GO2 Mouthpiece; Participants assigned to use the Bidirectional Oxygenation Valve (GO2 Mouthpiece) after surgery.	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.; Other Names: Bidirectional Oxygenation Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial Pressure of Oxygen (PaO2 Level)	Partial pressure of oxygen is a measurement of oxygen pressure in arterial blood. It reflects how well oxygen is able to move from the lungs to the blood. Normal values are 80 to 100 millimeters of mercury (mmHg).	1, 6, 12 and 24 hours postextubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Normal Atelectasis Score	Atelectasis is a lung condition that happens when the airways don't expand normally. Atelectasis is measured with the modified radiological atelectasis score (m-RAS). Each pulmonary lobe, including the lingula, is scored 0-3 (0=normal, 1=plate or minor infiltrate, 2= moderate atelectasis, 3= total atelectasis). The scores of the six lobes are then summed to give a total score ranging from 0 to 18 with higher scores being associated with worse outcomes. For this analysis, scores were categorized as 0 (normal) or greater than 0 (not normal). The count of participants with a normal atelectasis score at the indicated time point are presented here.	Immediately postoperative, Postoperative days 1, 2, 3, 4
Oxygen Requirement	Oxygen was provided by a nasal cannula. The flow rate of supplemental oxygen that participants required after surgery is assessed as liters per minute. Higher flow rate indicates an increased need for supplemental oxygen.	Postextubation Hours 1, 6, 12 and 24, Postoperative Days 2, 3, and 4
Carbon Dioxide Level	Normal carbon dioxide (CO2) levels in blood range from 35.0 mmHg to 45.0 mmHg.	Postextubation Hours 1, 6, 12 and 24
FEV1	Forced expiratory volume in one second (FEV1) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FEV1 is the amount of air forced from lungs in one second. To describe severity of pulmonary disease, FEV1 can be expressed as a percentage of the predicted value. Values 80% and and greater of the predicted value are considered normal.	Preoperative and postoperative day 3
Forced Vital Capacity (FVC)	Forced vital capacity (FVC) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FVC is the total amount of air exhaled during the FEV test. FVC can be expressed as a percentage of the predicted value.The normal range for the percent of the predicted value is between 80% and 120%.	Preoperative, Postoperative Day 3
Respiratory Rate	Respiratory rate is the number of breaths taken per minute. The normal respiration rate for an adult at rest is 16 to 20 breaths per minute.	Postextubation Hours 1, 6, 12 and 24, Postoperative Days 2, 3, and 4
Body Temperature	Measure of heat associated with the metabolism of the body. Normal range is between 36.5-37.5 degrees Celsius (°C).	Immediately Postoperative, Postoperative Day 1, 2, 3, 4

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: PEEP Medical, LLC
• Investigators: Principal Investigator: Jeffrey Miller, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: February 1, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative pulmonary complications; Cardiac surgery; Coronary bypass; Heart valve replacement
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: IRB00117254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No