Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
Primary Purpose
Pulmonary Disease, Postoperative Complications
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EzPAP
Metaneb
Intermittent Positive Pressure Breathing (IPPB)
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Disease
Eligibility Criteria
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
Sites / Locations
- UT Southwestern Clements University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
EzPAP
Metaneb
Intermittent Positive Pressure Breathing (IPPB)
Arm Description
The patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily
The patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily
The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04164173
First Posted
November 8, 2019
Last Updated
February 25, 2023
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04164173
Brief Title
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
Official Title
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Postoperative Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessment respiratory therapist will be blinded to respiratory therapy modalities.
Allocation
Randomized
Enrollment
324 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EzPAP
Arm Type
Experimental
Arm Description
The patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily
Arm Title
Metaneb
Arm Type
Experimental
Arm Description
The patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily
Arm Title
Intermittent Positive Pressure Breathing (IPPB)
Arm Type
Experimental
Arm Description
The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily
Intervention Type
Device
Intervention Name(s)
EzPAP
Other Intervention Name(s)
Postoperative hyperinflation therapy-EzPAP
Intervention Description
Patient will receive 10 min EzPAP 4 times daily
Intervention Type
Device
Intervention Name(s)
Metaneb
Other Intervention Name(s)
Postoperative hyperinflation therapy-Metaneb
Intervention Description
Patient will receive 10 min Metaneb 4 times daily
Intervention Type
Device
Intervention Name(s)
Intermittent Positive Pressure Breathing (IPPB)
Other Intervention Name(s)
Postoperative hyperinflation therapy-IPPB
Intervention Description
Patient will receive 10 min IPPB 4 times daily
Primary Outcome Measure Information:
Title
Postoperative lung function as assessed by the changes in FEV1/FVC
Description
The postoperative changes in the Forced Expiratory Volume in one second (FEV1)/the Forced Vital Capacity (FVC) in microspirometry
Time Frame
Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaffer Odeh, MD
Phone
214-786-1067
Email
Jaffer.Odeh@UTSouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Melikman, RN
Phone
214-645-7011
Email
Emily.Melikman@UTSouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaffer Odeh, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
UT Southwestern Clements University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl Mansir, RT
Phone
214-633-4791
Email
Cheryl.Mansir@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Gabriel Rodriguez, RT
Phone
214/633-4791
Email
Gabriel.Rodriguez@utsouthwestern.edu
12. IPD Sharing Statement
Learn more about this trial
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
We'll reach out to this number within 24 hrs