Postoperative AtelectasisNCT04253834
GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis
A study testing Incentive spirometer and GO2 Mouthpiece in people with Postoperative Atelectasis, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Atelectasis
- What is being tested?
- Incentive spirometer and GO2 Mouthpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2020to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing coronary artery bypass surgery (CABG) and/or valve replacement surgery
- Able to provide written informed consent
- Maintenance of an arterial line postoperatively
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: 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.
Read the 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
- Being tested
- Incentive spirometer, GO2 Mouthpiece
- Keywords
- Cardiac surgery, Coronary bypass, Heart valve replacement, Postoperative pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive spirometerDevice
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 MouthpieceDevice
Also called Bidirectional Oxygenation Valve
The GO2 Mouthpiece is a simple, comfortable, and straightforward silicone rubber-made, bidirectional oxygenation mouthpiece that effectively delivers PEEP with every breath.
| Study group | Role | What they receive |
|---|---|---|
| Incentive Spirometer Control Arm | Active comparator | Participants assigned to use the incentive spirometer after surgery. Receives: Device: Incentive spirometer |
| GO2 Mouthpiece | Experimental | Participants assigned to use the Bidirectional Oxygenation Valve (GO2 Mouthpiece) after surgery. Receives: Device: GO2 Mouthpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1, 6, 12 and 24 hours postextubation
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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).
Measured: Immediately Postoperative, Postoperative Day 1, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start27 Aug 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative AtelectasisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, prospective, randomized controlled study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- PEEP Medical, LLC
- Responsible party
- Principal investigator, Jeffrey Miller, Emory University
- Investigators
- Jeffrey Miller, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253834
- Sponsor's protocol ID
- IRB00117254
- Status last verified
- Jan 2022
- First submitted
- 22 Jan 2020
- Last updated
- 15 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GO2 PEEP Study: The Use of a Bidirectional Oxygenation Valve in the Prevention and Management of Postoperative Atelectasis
- ClinicalTrials.gov ID
- NCT04253834
- Acronym / sponsor ID
- IRB00117254
- Conditions
- Postoperative Atelectasis
- Keywords
- Cardiac surgery, Coronary bypass, Heart valve replacement, Postoperative pulmonary complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- PEEP Medical, LLC
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 15 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, prospective, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Incentive Spirometer Control Arm | Active comparator | Device: Incentive spirometerParticipants assigned to use the incentive spirometer after surgery. |
| GO2 Mouthpiece | Experimental | Device: GO2 MouthpieceParticipants assigned to use the Bidirectional Oxygenation Valve (GO2 Mouthpiece) after surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing coronary artery bypass surgery (CABG) and/or valve replacement surgery
- Able to provide written informed consent
- Maintenance of an arterial line postoperatively
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentive spirometerThe 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. | Device | Incentive Spirometer Control Arm |
| GO2 MouthpieceAlso: Bidirectional Oxygenation ValveThe GO2 Mouthpiece is a simple, comfortable, and straightforward silicone rubber-made, bidirectional oxygenation mouthpiece that effectively delivers PEEP with every breath. | Device | GO2 Mouthpiece |
Primary outcome
Partial Pressure of Oxygen (PaO2 Level)
Time frame: 1, 6, 12 and 24 hours postextubation
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).
7 secondary outcomes
Number of Participants With Normal Atelectasis Score
Time frame: Immediately postoperative, Postoperative days 1, 2, 3, 4
Oxygen Requirement
Time frame: Postextubation Hours 1, 6, 12 and 24, Postoperative Days 2, 3, and 4
Carbon Dioxide Level
Time frame: Postextubation Hours 1, 6, 12 and 24
FEV1
Time frame: Preoperative and postoperative day 3
Forced Vital Capacity (FVC)
Time frame: Preoperative, Postoperative Day 3
Respiratory Rate
Time frame: Postextubation Hours 1, 6, 12 and 24, Postoperative Days 2, 3, and 4
Body Temperature
Time frame: Immediately Postoperative, Postoperative Day 1, 2, 3, 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Postoperative Atelectasis
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Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
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Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Enrolling by invitation
Evaluation of the Effectiveness of Lung-Protective Ventilation in Patients Undergoing Laparoscopic Gastrectomy
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Not yet recruiting
Flow-Controlled vs. Pressure-Controlled Ventilation in CABG: Effects on Lung Aeration and Diaphragm Function
Coronary Artery Disease, Postoperative Pulmonary Complications
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Effect of Inspired Oxygen Concentration on Postoperative Atelectasis After VATS Lobectomy
Atelectasis, Postoperative Pulmonary Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Miller, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive spirometer and GO2 Mouthpiece in people with Postoperative Atelectasis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial Pressure of Oxygen (PaO2 Level) (time frame: 1, 6, 12 and 24 hours postextubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022; AzTrials last refreshed its copy on 27 Oct 2026.