Pulmonary DiseaseNCT04164173
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
A study testing EzPAP, Metaneb and Intermittent Positive Pressure Breathing (IPPB) in people with Pulmonary Disease and Postoperative Complications, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this prospective randomized clinical trial is to evaluate three different types of hyperinflation respiratory therapies, Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), Metaneb. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Disease, Postoperative Complications
- What is being tested?
- EzPAP, Metaneb and Intermittent Positive Pressure Breathing (IPPB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Admitted to Cardiovascular ICU (CVICU) after coronary artery bypass grafting (CABG), isolated valve repair/replacement, or CABG + valve repair/replacement
- Cardiac surgery performed via median sternotomy
Who cannot join
- BMI>40
- Refusal to be consented
- Prior or current lung transplant patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Clements University Hospital
Dallas, Texas, 75390
Cheryl Mansir, RT, 214/633-4791, Cheryl.Mansir@UTSouthwestern.edu
Gabriel Rodriguez, RT, 214/633-4791, Gabriel.Rodriguez@utsouthwestern.edu
About this study
Official title: Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial
The purpose of this prospective randomized clinical trial is to evaluate three different types of hyperinflation respiratory therapies, Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), Metaneb. Investigators will examine which hyperinflation therapy provides better lung expansion and may improve lung recovery after surgery.
Read the detailed description
Postoperative pain due to surgical incision may limit lung expansion. After cardiac surgery, all patients receive respiratory therapies, because it is critical to expand lung after surgery to prevent respiratory complications such as lung collapse (atelectasis) due to shallow breathing or accumulation of airway secretions.
Although incentive spirometer is the most common method used for lung recovery after cardiac surgery, some studies were not able to find any benefits from the use of incentive spirometer. Inspiratory positive-pressure breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), and chest airway clearance (Metaneb) are hyperinflation therapies used after surgery. The purpose of this research study is to determine which hyperinflation respiratory therapy provide better lung recovery after cardiac surgery.
Hyperinflation Respiratory Therapies:Participants will be randomly assigned one of the hyperinflation respiratory therapy, intermittent positive pressure breathing (IPPB) and the EzPAP or the Metaneb.
- Intermittent positive pressure breathing (IPPB) is a respiratory therapy technique which will support your breathing by providing pressure support. This respiratory method will increase air volume breathing in.
- The EzPAP is another respiratory treatment and participants will breath against to resistance in order to prolong the time the lung remain open.
- The Metaneb will provide resistance when patients breathing in order to prolong the lung opening.
Hyperinflation therapy will be performed every 4 hours in the intensive care unit (ICU). Each respiratory therapy session will take about 15 minutes. Participants' pulmonary function will be evaluated daily to monitor the lung recovery with microspirometer which will take place approximately 5 minutes. Total study duration is about 96 hours after surgery or until discharge from the Intensive Care Unit.
Risk for Lung over expansion (hyperinflation) therapy:
Hyperinflation respiratory treatments target to expand your lung to prevent complication such as collapse of small airway after surgery. This over expansion of your lung may increase work of breathing. All expected complications are typical in the post-operative cardiac patients and not unique to hyperinflation therapy.
The possible complications listed below:
- Over distention of air sucks (alveoli). Sometimes pressure trauma in your lung may cause pneumothorax.
- Infection
- Bloody sputum (hemoptysis)
- Blood gas changes such as decrease carbon dioxide or increase oxygen in your blood.
- Sometimes stomach may distend
- Impaction of airway secretions if gas mixture not humidified enough.
- Your blood return to the heart maybe decreased which may affect your blood pressure.
- Exacerbation of low blood oxygen level (hypoxemia),
- Decreased or increased respiration
- Air trapping in your airway
- You may psychologically dependence to device
- Conditions
- Pulmonary Disease, Postoperative Complications
- Being tested
- EzPAP, Metaneb, Intermittent Positive Pressure Breathing (IPPB)
- Medical subject headings
- Lung Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzPAPDevice
Also called Postoperative hyperinflation therapy-EzPAP
Patient will receive 10 min EzPAP 4 times daily
MetanebDevice
Also called Postoperative hyperinflation therapy-Metaneb
Patient will receive 10 min Metaneb 4 times daily
Intermittent Positive Pressure Breathing (IPPB)Device
Also called Postoperative hyperinflation therapy-IPPB
Patient will receive 10 min IPPB 4 times daily
| Study group | Role | What they receive |
|---|---|---|
| EzPAP | Experimental | The patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily Receives: Device: EzPAP |
| Metaneb | Experimental | The patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily Receives: Device: Metaneb |
| Intermittent Positive Pressure Breathing (IPPB) | Experimental | The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily Receives: Device: Intermittent Positive Pressure Breathing (IPPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative lung function as assessed by the changes in FEV1/FVC
The postoperative changes in the Forced Expiratory Volume in one second (FEV1)/the Forced Vital Capacity (FVC) in microspirometry
Measured: Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start15 Jun 2020
- Primary completion1 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaffer Odeh, University of Texas Southwestern Medical Center
- Investigators
- Jaffer Odeh, MD, Study chair, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164173
- Sponsor's protocol ID
- STU-2019-1242
- Status last verified
- Oct 2025
- First submitted
- 8 Nov 2019
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT04164173
- Acronym / sponsor ID
- STU-2019-1242
- Conditions
- Pulmonary Disease, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective randomized clinical trial is to evaluate three different types of hyperinflation respiratory therapies, Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), Metaneb. Investigators will examine which hyperinflation therapy provides better lung expansion and may improve lung recovery after surgery.
Detailed description
Postoperative pain due to surgical incision may limit lung expansion. After cardiac surgery, all patients receive respiratory therapies, because it is critical to expand lung after surgery to prevent respiratory complications such as lung collapse (atelectasis) due to shallow breathing or accumulation of airway secretions.
Although incentive spirometer is the most common method used for lung recovery after cardiac surgery, some studies were not able to find any benefits from the use of incentive spirometer. Inspiratory positive-pressure breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), and chest airway clearance (Metaneb) are hyperinflation therapies used after surgery. The purpose of this research study is to determine which hyperinflation respiratory therapy provide better lung recovery after cardiac surgery.
Hyperinflation Respiratory Therapies:Participants will be randomly assigned one of the hyperinflation respiratory therapy, intermittent positive pressure breathing (IPPB) and the EzPAP or the Metaneb.
- Intermittent positive pressure breathing (IPPB) is a respiratory therapy technique which will support your breathing by providing pressure support. This respiratory method will increase air volume breathing in.
- The EzPAP is another respiratory treatment and participants will breath against to resistance in order to prolong the time the lung remain open.
- The Metaneb will provide resistance when patients breathing in order to prolong the lung opening.
Hyperinflation therapy will be performed every 4 hours in the intensive care unit (ICU). Each respiratory therapy session will take about 15 minutes. Participants' pulmonary function will be evaluated daily to monitor the lung recovery with microspirometer which will take place approximately 5 minutes. Total study duration is about 96 hours after surgery or until discharge from the Intensive Care Unit.
Risk for Lung over expansion (hyperinflation) therapy:
Hyperinflation respiratory treatments target to expand your lung to prevent complication such as collapse of small airway after surgery. This over expansion of your lung may increase work of breathing. All expected complications are typical in the post-operative cardiac patients and not unique to hyperinflation therapy.
The possible complications listed below:
- Over distention of air sucks (alveoli). Sometimes pressure trauma in your lung may cause pneumothorax.
- Infection
- Bloody sputum (hemoptysis)
- Blood gas changes such as decrease carbon dioxide or increase oxygen in your blood.
- Sometimes stomach may distend
- Impaction of airway secretions if gas mixture not humidified enough.
- Your blood return to the heart maybe decreased which may affect your blood pressure.
- Exacerbation of low blood oxygen level (hypoxemia),
- Decreased or increased respiration
- Air trapping in your airway
- You may psychologically dependence to device
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EzPAP | Experimental | Device: EzPAPThe patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily |
| Metaneb | Experimental | Device: MetanebThe patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily |
| Intermittent Positive Pressure Breathing (IPPB) | Experimental | Device: Intermittent Positive Pressure Breathing (IPPB)The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and older
- Admitted to Cardiovascular ICU (CVICU) after coronary artery bypass grafting (CABG), isolated valve repair/replacement, or CABG + valve repair/replacement
- Cardiac surgery performed via median sternotomy
Key exclusion criteria (3 listed)
- BMI>40
- Refusal to be consented
- Prior or current lung transplant patients
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 |
|---|---|---|
| EzPAPAlso: Postoperative hyperinflation therapy-EzPAPPatient will receive 10 min EzPAP 4 times daily | Device | EzPAP |
| MetanebAlso: Postoperative hyperinflation therapy-MetanebPatient will receive 10 min Metaneb 4 times daily | Device | Metaneb |
| Intermittent Positive Pressure Breathing (IPPB)Also: Postoperative hyperinflation therapy-IPPBPatient will receive 10 min IPPB 4 times daily | Device | Intermittent Positive Pressure Breathing (IPPB) |
Primary outcome
Postoperative lung function as assessed by the changes in FEV1/FVC
Time frame: Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first.
The postoperative changes in the Forced Expiratory Volume in one second (FEV1)/the Forced Vital Capacity (FVC) in microspirometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
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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.
Jaffer Odeh, MD study chair
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EzPAP, Metaneb and Intermittent Positive Pressure Breathing (IPPB) in people with Pulmonary Disease and Postoperative Complications, run by University of Texas Southwestern Medical Center 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 3 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: looking for participants now, as of the sponsor's last update on 4 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaffer Odeh, MD (214-786-1067, Jaffer.Odeh@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative lung function as assessed by the changes in FEV1/FVC (time frame: Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first.). 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 4 Nov 2025.