Trial Outcomes & Findings for Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19 (NCT NCT04331366)
NCT ID: NCT04331366
Last Updated: 2021-02-18
Results Overview
Pulse oximetry is a way to assess whether or not a patient needs help breathing. Oxygen saturation levels for healthy individuals are 95% and above.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)
Results posted on
2021-02-18
Participant Flow
Participants were enrolled at Emory Saint Joseph's Hospital and Emory University Hospital in Atlanta, Georgia. Enrollment began on April 8, 2020 and all follow up was complete by August 31, 2020.
Participant milestones
| Measure |
GO2 PEEP MOUTHPIECE
Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19
Baseline characteristics by cohort
| Measure |
GO2 PEEP MOUTHPIECE
n=2 Participants
Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
|
|---|---|
|
Age, Continuous
|
60.71 years
STANDARD_DEVIATION 21.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)Pulse oximetry is a way to assess whether or not a patient needs help breathing. Oxygen saturation levels for healthy individuals are 95% and above.
Outcome measures
| Measure |
GO2 PEEP MOUTHPIECE
n=2 Participants
Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
|
|---|---|
|
Oxygen Saturation by Pulse Oximetry
Baseline
|
92 percentage of oxygen saturation
Standard Deviation 0
|
|
Oxygen Saturation by Pulse Oximetry
Minute 5
|
93.5 percentage of oxygen saturation
Standard Deviation 0.707
|
|
Oxygen Saturation by Pulse Oximetry
Minute 10
|
94 percentage of oxygen saturation
Standard Deviation 1.414
|
|
Oxygen Saturation by Pulse Oximetry
Minute 15
|
94 percentage of oxygen saturation
Standard Deviation 1.414
|
|
Oxygen Saturation by Pulse Oximetry
Minute 30 (15 minutes post-treatment)
|
92.5 percentage of oxygen saturation
Standard Deviation 0.707
|
SECONDARY outcome
Timeframe: Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)The number of breaths per minute was assessed before treatment, during treatment, and 15 minutes after the end of treatment.
Outcome measures
| Measure |
GO2 PEEP MOUTHPIECE
n=2 Participants
Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
|
|---|---|
|
Respiratory Rate
Baseline
|
23.5 breaths per minute
Standard Deviation 0.707
|
|
Respiratory Rate
Minute 5
|
20 breaths per minute
Standard Deviation 0
|
|
Respiratory Rate
Minute 10
|
18 breaths per minute
Standard Deviation 0
|
|
Respiratory Rate
Minute 15
|
17 breaths per minute
Standard Deviation 1.414
|
|
Respiratory Rate
Minute 30 (15 minutes post-treatment)
|
18.5 breaths per minute
Standard Deviation 0.707
|
SECONDARY outcome
Timeframe: Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)Heart rate, in beats per minute, was assessed before treatment, during treatment, and 15 minutes after the end of treatment.
Outcome measures
| Measure |
GO2 PEEP MOUTHPIECE
n=2 Participants
Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
|
|---|---|
|
Heart Rate
Baseline
|
84.5 beats per minute
Standard Deviation 17.678
|
|
Heart Rate
Minute 5
|
87.5 beats per minute
Standard Deviation 17.678
|
|
Heart Rate
Minute 10
|
90.5 beats per minute
Standard Deviation 20.506
|
|
Heart Rate
Minute 15
|
86.5 beats per minute
Standard Deviation 16.263
|
|
Heart Rate
Minute 30 (15 minutes post-treatment)
|
86.5 beats per minute
Standard Deviation 14.849
|
SECONDARY outcome
Timeframe: Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)Systolic and diastolic blood pressure was assessed before treatment, during treatment, and 15 minutes after the end of treatment.
Outcome measures
| Measure |
GO2 PEEP MOUTHPIECE
n=2 Participants
Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
|
|---|---|
|
Blood Pressure
Baseline Systolic
|
152.5 mmHg
Standard Deviation 31.820
|
|
Blood Pressure
Baseline Diastolic
|
65 mmHg
Standard Deviation 7.071
|
|
Blood Pressure
Minute 5 Systolic
|
155 mmHg
Standard Deviation 21.213
|
|
Blood Pressure
Minute 5 Diastolic
|
72.5 mmHg
Standard Deviation 10.607
|
|
Blood Pressure
Minute 10 Systolic
|
150 mmHg
Standard Deviation 21.213
|
|
Blood Pressure
Minute 10 Diastolic
|
70 mmHg
Standard Deviation 0
|
|
Blood Pressure
Minute 15 Systolic
|
145 mmHg
Standard Deviation 21.213
|
|
Blood Pressure
Minute 15 Diastolic
|
67.5 mmHg
Standard Deviation 3.536
|
|
Blood Pressure
Minute 30 (15 minutes post-treatment) Systolic
|
152.5 mmHg
Standard Deviation 24.749
|
|
Blood Pressure
Minute 30 (15 minutes post-treatment) Diastolic
|
65 mmHg
Standard Deviation 7.071
|
SECONDARY outcome
Timeframe: Baseline, Minutes 5, 10, 15, 30 (15 minutes after treatment ends)Population: Data on subjective work of breathing were not collected at the Baseline and Minute 30 time points.
Participants were observed for stridor, grunting, nasal flaring, or accessory muscle use. The presence of any of these indicates that increased effort is required for breathing.
Outcome measures
| Measure |
GO2 PEEP MOUTHPIECE
n=2 Participants
Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
|
|---|---|
|
Count of Participants With Subjective Work of Breathing
Minute 5
|
1 Participants
|
|
Count of Participants With Subjective Work of Breathing
Minute 10
|
0 Participants
|
|
Count of Participants With Subjective Work of Breathing
Minute 15
|
0 Participants
|
Adverse Events
GO2 PEEP MOUTHPIECE
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GO2 PEEP MOUTHPIECE
n=2 participants at risk
Participants receiving treatment with the GO2 PEEP MOUTHPIECE.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Decrease in oxygen saturation after cessation of PEEP therapy
|
50.0%
1/2 • Participants were assessed for adverse events on the day of the intervention beginning just prior to treatment with the mouthpiece through 15 minutes after the cessation of PEEP therapy, for a total of up to 30 minutes.
Participants were assessed for the following adverse events: * Decreased oxygen saturation * Increased respiratory rate * Increased heart rate * Low blood pressure * Increased work of breathing * Worsening arterial blood gases (if available) * Inability to tolerate the mouthpiece
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place