- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164173
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jaffer Odeh, MD
- Phone Number: 214-786-1067
- Email: Jaffer.Odeh@UTSouthwestern.edu
Study Contact Backup
- Name: Emily Melikman, RN
- Phone Number: 214-645-7011
- Email: Emily.Melikman@UTSouthwestern.edu
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern Clements University Hospital
-
Contact:
- Cheryl Mansir, RT
- Phone Number: 214-633-4791
- Email: Cheryl.Mansir@UTSouthwestern.edu
-
Contact:
- Gabriel Rodriguez, RT
- Phone Number: 214/633-4791
- Email: Gabriel.Rodriguez@utsouthwestern.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- BMI>40
- Refusal to be consented
- Prior or current lung transplant patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EzPAP
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 Names:
|
Experimental: Metaneb
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 Names:
|
Experimental: Intermittent Positive Pressure Breathing (IPPB)
The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily
|
Patient will receive 10 min IPPB 4 times daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first.
|
Collaborators and Investigators
Investigators
- Study Chair: Jaffer Odeh, MD, UT Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU-2019-1242
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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