GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Diseases
- Heart Valve Diseases
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Single center, prospective, randomized controlled studyMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
The purpose of this study is to compare a novel breathing device, called the GO2 device, which uses the concept of Positive End Expiratory Pressure (PEEP) to the standard breathing tool called the Incentive Spirometer (IS), thus improving respiratory dynamics of the postoperative patient. The standa...
The purpose of this study is to compare a novel breathing device, called the GO2 device, which uses the concept of Positive End Expiratory Pressure (PEEP) to the standard breathing tool called the Incentive Spirometer (IS), thus improving respiratory dynamics of the postoperative patient. The standard of care is for patients to receive the incentive spirometer (IS). Patients will be randomized to use either the novel GO2 breathing device or the IS. Patients will also have the following tests: Baseline (within 30 days of surgery) Undergo a pulmonary function test (PFT). This test measures how well the lungs work. This includes how well patients are able to breathe and how effective their lungs are able to bring oxygen to the rest of the body. Will have a chest x-ray. Post-Open Heart Surgery Will use the novel GO2 breathing device or the IS for 5 minutes every hour awake after surgery. Will have blood drawn at 1, 6, 12 and 24 hours after the breathing tube is removed. Will have a chest x-ray immediately after surgery and Days 1-4 after surgery. Will have a pulmonary function test on Day 3 after surgery. Patient's respiratory rate will be recorded 1, 6, 12 and 24 hours after breathing tube is removed, then daily each morning. Patient's peak body temperature will be recorded every 24 hours. This study will utilize a single center, prospective, randomized controlled pilot study design. There will be a total of 20 patients enrolled in this study at Emory Saint Joseph's Hospital.
Tracking Information
- NCT #
- NCT04253834
- Collaborators
- PEEP Medical, LLC
- Investigators
- Principal Investigator: Jeffrey Miller, MD Emory University