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GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis

Primary Purpose

Postoperative Atelectasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incentive spirometer
GO2 Mouthpiece
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Atelectasis focused on measuring Cardiac surgery, Coronary bypass, Heart valve replacement, Postoperative pulmonary complications

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Saint Joseph's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Incentive Spirometer Control Arm

GO2 Mouthpiece

Arm Description

Participants assigned to use the incentive spirometer after surgery.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
Carbon Dioxide Level
Normal carbon dioxide (CO2) levels in blood range from 35.0 mmHg to 45.0 mmHg.
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.
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%.
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.
Body Temperature
Measure of heat associated with the metabolism of the body. Normal range is between 36.5-37.5 degrees Celsius (°C).

Full Information

First Posted
January 22, 2020
Last Updated
January 21, 2022
Sponsor
Emory University
Collaborators
PEEP Medical, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04253834
Brief Title
GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis
Official Title
GO2 PEEP Study: The Use of a Bidirectional Oxygenation Valve in the Prevention and Management of Postoperative Atelectasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
PEEP Medical, LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Atelectasis
Keywords
Cardiac surgery, Coronary bypass, Heart valve replacement, Postoperative pulmonary complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center, prospective, randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incentive Spirometer Control Arm
Arm Type
Active Comparator
Arm Description
Participants assigned to use the incentive spirometer after surgery.
Arm Title
GO2 Mouthpiece
Arm Type
Experimental
Arm Description
Participants assigned to use the Bidirectional Oxygenation Valve (GO2 Mouthpiece) after surgery.
Intervention Type
Device
Intervention Name(s)
Incentive spirometer
Intervention Description
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
Intervention Name(s)
GO2 Mouthpiece
Other Intervention Name(s)
Bidirectional Oxygenation Valve
Intervention Description
The GO2 Mouthpiece is a simple, comfortable, and straightforward silicone rubber-made, bidirectional oxygenation mouthpiece that effectively delivers PEEP with every breath.
Primary Outcome Measure Information:
Title
Partial Pressure of Oxygen (PaO2 Level)
Description
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).
Time Frame
1, 6, 12 and 24 hours postextubation
Secondary Outcome Measure Information:
Title
Number of Participants With Normal Atelectasis Score
Description
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.
Time Frame
Immediately postoperative, Postoperative days 1, 2, 3, 4
Title
Oxygen Requirement
Description
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.
Time Frame
Postextubation Hours 1, 6, 12 and 24, Postoperative Days 2, 3, and 4
Title
Carbon Dioxide Level
Description
Normal carbon dioxide (CO2) levels in blood range from 35.0 mmHg to 45.0 mmHg.
Time Frame
Postextubation Hours 1, 6, 12 and 24
Title
FEV1
Description
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.
Time Frame
Preoperative and postoperative day 3
Title
Forced Vital Capacity (FVC)
Description
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%.
Time Frame
Preoperative, Postoperative Day 3
Title
Respiratory Rate
Description
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.
Time Frame
Postextubation Hours 1, 6, 12 and 24, Postoperative Days 2, 3, and 4
Title
Body Temperature
Description
Measure of heat associated with the metabolism of the body. Normal range is between 36.5-37.5 degrees Celsius (°C).
Time Frame
Immediately Postoperative, Postoperative Day 1, 2, 3, 4

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Undergoing coronary artery bypass surgery (CABG) and/or valve replacement surgery Able to provide written informed consent Maintenance of an arterial line postoperatively Exclusion Criteria Active smoking, within three months of surgery Forced expiratory volume in one second (FEV1) <75% predicted Relative risk to develop pulmonary barotrauma as evident by history of pneumothorax or emphysema Unable or unwilling to provide informed consent, cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Miller, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis

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