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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
Sponsor:
Information provided by (Responsible Party):
Jaffer Odeh, University of Texas Southwestern Medical Center

Brief 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. Investigators will examine which hyperinflation therapy provides better lung expansion and may improve lung recovery after surgery.

Condition or disease Intervention/treatment Phase
Pulmonary Disease Postoperative Complications Device: EzPAP Device: Metaneb Device: Intermittent Positive Pressure Breathing (IPPB) Not Applicable

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.

  1. 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.
  2. The EzPAP is another respiratory treatment and participants will breath against to resistance in order to prolong the time the lung remain open.
  3. 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:

  1. Over distention of air sucks (alveoli). Sometimes pressure trauma in your lung may cause pneumothorax.
  2. Infection
  3. Bloody sputum (hemoptysis)
  4. Blood gas changes such as decrease carbon dioxide or increase oxygen in your blood.
  5. Sometimes stomach may distend
  6. Impaction of airway secretions if gas mixture not humidified enough.
  7. Your blood return to the heart maybe decreased which may affect your blood pressure.
  8. Exacerbation of low blood oxygen level (hypoxemia),
  9. Decreased or increased respiration
  10. Air trapping in your airway
  11. You may psychologically dependence to device

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Assessment respiratory therapist will be blinded to respiratory therapy modalities.
Primary Purpose: Prevention
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

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
Device: EzPAP
Patient will receive 10 min EzPAP 4 times daily
Other Name: Postoperative hyperinflation therapy-EzPAP

Experimental: Metaneb
The patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily
Device: Metaneb
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years and older
  2. Admitted to Cardiovascular ICU (CVICU) after coronary artery bypass grafting (CABG), isolated valve repair/replacement, or CABG + valve repair/replacement
  3. Cardiac surgery performed via median sternotomy

Exclusion Criteria:

  1. BMI>40
  2. Refusal to be consented
  3. Prior or current lung transplant patients

Information from the National Library of Medicine

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


Contacts
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Contact: Jaffer Odeh, MD 214-786-1067 Jaffer.Odeh@UTSouthwestern.edu
Contact: Emily Melikman, RN 214-645-7011 Emily.Melikman@UTSouthwestern.edu

Locations
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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   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Study Chair: Seema Dave, MPH UT Southwestern Medical Center
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Responsible Party: Jaffer Odeh, Assistant Profesor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04164173    
Other Study ID Numbers: STU-2019-1242
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes