Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
BMI>40
Refusal to be consented
Prior or current lung transplant patients
Trial design
Design model
Parallel
Treatments tested in this trial
EzPAP
DevicePatient will receive 10 min EzPAP 4 times daily
Metaneb
DevicePatient will receive 10 min Metaneb 4 times daily
Intermittent Positive Pressure Breathing (IPPB)
DevicePatient will receive 10 min IPPB 4 times daily
Treatment groups
324 Participants
are divided into 3 treatment groupsGroup A: EzPAPExperimental treatment 1 intervention
Group B: MetanebExperimental treatment 1 intervention
Group C: Intermittent Positive Pressure Breathing (IPPB)Experimental treatment 1 intervention
Trial outcomes
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
Time frame
Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first.Sponsors and contacts
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Source ClinicalTrials.gov