GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis

  • STATUS
    Recruiting
  • days left to enroll
    71
  • participants needed
    20
  • sponsor
    Emory University
Updated on 26 January 2021
bypass graft

Summary

This is a single center, prospective, randomized controlled study, with the purpose of comparing 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.

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 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.

Details
Condition Heart disease, VALVULAR HEART DISEASE, Cardiovascular Disease, Heart Valve Disease, Cardiac Disease, cardiac diseases, heart diseases, cardiac disorders, cardiac disorder, heart disorder
Treatment Incentive Spirometer, GO2 Mouthpiece
Clinical Study IdentifierNCT04253834
SponsorEmory University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Undergoing coronary artery bypass surgery (CABG) and/or valve replacement surgery
Able to provide written informed consent
Maintenance of an arterial line postoperatively

Exclusion Criteria

Active smoking, within three months of surgery
FEV1 <75% predicted
Relative risk to develop pulmonary barotrauma as evident by history of pneumothorax or emphysema
Unable or unwilling to provide informed consent, cognitive impairment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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