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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.
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EzPAP | Experimental | The patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily |
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| Metaneb | Experimental | The patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily |
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| Intermittent Positive Pressure Breathing (IPPB) | Experimental | The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EzPAP | Device | Patient will receive 10 min EzPAP 4 times daily |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaffer Odeh, MD | Contact | 214-786-1067 | Jaffer.Odeh@UTSouthwestern.edu | |
| Emily Melikman, RN | Contact | 214-645-7011 | Emily.Melikman@UTSouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jaffer Odeh, MD | University of Texas Southwestern Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Clements University Hospital | Recruiting | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007384 | Intermittent Positive-Pressure Breathing |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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Assessment respiratory therapist will be blinded to respiratory therapy modalities.
| Metaneb | Device | Patient will receive 10 min Metaneb 4 times daily |
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| Intermittent Positive Pressure Breathing (IPPB) | Device | Patient will receive 10 min IPPB 4 times daily |
|
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| D012138 |
| Respiratory Therapy |