Hyperinflation Respiratory Therapies in Cardiac Surgery Patients

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04164173
Status
Recruiting
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Conditions

  • Postoperative Complications
  • Pulmonary Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • EzPAP — DEVICE
    Patient will receive 10 min EzPAP 4 times daily
  • Metaneb — DEVICE
    Patient will receive 10 min Metaneb 4 times daily
  • Intermittent Positive Pressure Breathing (IPPB) — DEVICE
    Patient will receive 10 min IPPB 4 times daily

Study Details

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.

Key Dates

Start date
Jun 15, 2020
Status verified
Oct 2025
Primary completion
Aug 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: EzPAP
    The patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily
  • Experimental: Metaneb
    The patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily
  • Experimental: Intermittent Positive Pressure Breathing (IPPB)
    The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Clements University HospitalDallasTexas75390
Cheryl Mansir, RT
[email protected]
214/633-4791
Gabriel Rodriguez, RT
[email protected]
214/633-4791

Find similar trials in Dallas, TX

By research site
UT Southwestern Clements University Hospital· Dallas, TX

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