Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
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|ClinicalTrials.gov Identifier: NCT04164173|
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease Postoperative Complications||Device: EzPAP Device: Metaneb Device: Intermittent Positive Pressure Breathing (IPPB)||Not Applicable|
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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||324 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Assessment respiratory therapist will be blinded to respiratory therapy modalities.|
|Official Title:||Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial|
|Actual Study Start Date :||June 15, 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
The patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily
Patient will receive 10 min EzPAP 4 times daily
Other Name: Postoperative hyperinflation therapy-EzPAP
The patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily
Patient will receive 10 min Metaneb 4 times daily
Other Name: Postoperative hyperinflation therapy-Metaneb
Experimental: Intermittent Positive Pressure Breathing (IPPB)
The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily
Device: Intermittent Positive Pressure Breathing (IPPB)
Patient will receive 10 min IPPB 4 times daily
Other Name: Postoperative hyperinflation therapy-IPPB
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164173
|Contact: Jaffer Odeh, MD||214-786-1067||Jaffer.Odeh@UTSouthwestern.edu|
|Contact: Emily Melikman, RN||214-645-7011||Emily.Melikman@UTSouthwestern.edu|
|United States, Texas|
|UT Southwestern Clements University Hospital||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Cheryl Mansir, RT 214-633-4791 Cheryl.Mansir@UTSouthwestern.edu|
|Contact: Gabriel Rodriguez, RT 214/633-4791 Gabriel.Rodriguez@utsouthwestern.edu|
|Study Chair:||Seema Dave, MPH||UT Southwestern Medical Center|