UT Southwestern Clements University Hospital
Dallas, Texas, 75390, United States
Location status: Recruiting
Location contact
Cheryl Mansir, RT
CONTACT
214/633-4791
Gabriel Rodriguez, RT
CONTACT
214/633-4791
NCT Number: NCT04164173
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75390, United States
Location status: Recruiting
Cheryl Mansir, RT
CONTACT
214/633-4791
Gabriel Rodriguez, RT
CONTACT
214/633-4791
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient will receive 10 min EzPAP 4 times daily
Other names: Postoperative hyperinflation therapy-EzPAP
Patient will receive 10 min Metaneb 4 times daily
Other names: Postoperative hyperinflation therapy-Metaneb
Patient will receive 10 min IPPB 4 times daily
Other names: Postoperative hyperinflation therapy-IPPB
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
Contact information is provided by the study sponsor or research team.
Emily Melikman, RN
CONTACT
Jaffer Odeh, MD
CONTACT
University of Texas Southwestern Medical Center
Other
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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