Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
1 other identifier
interventional
324
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedStudy Start
First participant enrolled
June 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
November 4, 2025
October 1, 2025
8.1 years
November 8, 2019
October 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first.
Study Arms (3)
EzPAP
EXPERIMENTALThe patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily
Metaneb
EXPERIMENTALThe patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily
Intermittent Positive Pressure Breathing (IPPB)
EXPERIMENTALThe patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily
Interventions
Patient will receive 10 min EzPAP 4 times daily
Patient will receive 10 min Metaneb 4 times daily
Patient will receive 10 min IPPB 4 times daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- BMI\>40
- Refusal to be consented
- Prior or current lung transplant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Clements University Hospital
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jaffer Odeh, MD
University of Texas Southwestern Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessment respiratory therapist will be blinded to respiratory therapy modalities.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Profesor
Study Record Dates
First Submitted
November 8, 2019
First Posted
November 15, 2019
Study Start
June 15, 2020
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
November 4, 2025
Record last verified: 2025-10