N/A
N=20
GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis
Postoperative Atelectasis
Bottom Line
View on ClinicalTrials.gov: NCT04253834 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Partial Pressure of Oxygen (PaO2 Level) — 95.4; 83.5; 92.1; 85.4 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Incentive spirometer (Device); GO2 Mouthpiece (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Partial Pressure of Oxygen (PaO2 Level) |
95.4; 83.5; 92.1; 85.4; 91.0; 81.4 | — |
| SECONDARY Number of Participants With Normal Atelectasis Score |
0; 2; 0; 0; 0; 0 | — |
| SECONDARY Oxygen Requirement |
3.7; 3.7; 2.3; 2.4; 2.2; 2.1 | — |
| SECONDARY Carbon Dioxide Level |
38.2; 39; 37.0; 37.2; 37.3; 36.9 | — |
| SECONDARY FEV1 |
86.4; 93.7; 35.9; 43.1 | — |
| SECONDARY Forced Vital Capacity (FVC) |
85.7; 90.1; 38.0; 41.6 | — |
| SECONDARY Respiratory Rate |
21.3; 20.5; 21.2; 17.9; 21.0; 19.2 | — |
| SECONDARY Body Temperature |
36.8; 36.8; 38.0; 37.7; 37.5; 37.4 | — |
Summary
This study compares a novel breathing device, called the GO2 Mouthpiece, to the standard breathing tool called the incentive spirometer, thus improving respiratory dynamics of the postoperative patient.
Eligibility Criteria
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
- Forced expiratory volume in one second (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
Data sourced from ClinicalTrials.gov (NCT04253834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.