Trial Outcomes & Findings for GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis (NCT NCT04253834)
NCT ID: NCT04253834
Last Updated: 2022-02-15
Results Overview
Partial pressure of oxygen is a measurement of oxygen pressure in arterial blood. It reflects how well oxygen is able to move from the lungs to the blood. Normal values are 80 to 100 millimeters of mercury (mmHg).
COMPLETED
NA
20 participants
1, 6, 12 and 24 hours postextubation
2022-02-15
Participant Flow
Participant enrollment began August 27, 2020 and all study follow up was completed January 31, 2021. Participants were enrolled at Emory Saint Joseph's Hospital in Atlanta, Georgia, USA.
Participant milestones
| Measure |
Incentive Spirometer Control Arm
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
Participants using the bidirectional oxygenation valve, GO2 Mouthpiece, after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis
Baseline characteristics by cohort
| Measure |
Incentive Spirometer Control Arm
n=10 Participants
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
n=10 Participants
Participants using the GO2 Mouthpiece after surgery.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1, 6, 12 and 24 hours postextubationPartial pressure of oxygen is a measurement of oxygen pressure in arterial blood. It reflects how well oxygen is able to move from the lungs to the blood. Normal values are 80 to 100 millimeters of mercury (mmHg).
Outcome measures
| Measure |
Incentive Spirometer Control Arm
n=10 Participants
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
n=10 Participants
Participants using the GO2 Mouthpiece after surgery.
|
|---|---|---|
|
Partial Pressure of Oxygen (PaO2 Level)
1 hour postextubation
|
95.4 mmHg
Standard Deviation 22.6
|
83.5 mmHg
Standard Deviation 18.3
|
|
Partial Pressure of Oxygen (PaO2 Level)
6 hours postextubation
|
92.1 mmHg
Standard Deviation 28.1
|
85.4 mmHg
Standard Deviation 22.3
|
|
Partial Pressure of Oxygen (PaO2 Level)
12 hours postextubation
|
91.0 mmHg
Standard Deviation 21.8
|
81.4 mmHg
Standard Deviation 17.9
|
|
Partial Pressure of Oxygen (PaO2 Level)
24 hours postextubation
|
74.5 mmHg
Standard Deviation 17.2
|
77.8 mmHg
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: Immediately postoperative, Postoperative days 1, 2, 3, 4Population: This analysis includes participants who completed the chest x-ray at the indicated visits. The atelectasis score could not be determined for one participant at postoperative day 3 and two participants at postoperative day 4 because chest x-rays were not performed.
Atelectasis is a lung condition that happens when the airways don't expand normally. Atelectasis is measured with the modified radiological atelectasis score (m-RAS). Each pulmonary lobe, including the lingula, is scored 0-3 (0=normal, 1=plate or minor infiltrate, 2= moderate atelectasis, 3= total atelectasis). The scores of the six lobes are then summed to give a total score ranging from 0 to 18 with higher scores being associated with worse outcomes. For this analysis, scores were categorized as 0 (normal) or greater than 0 (not normal). The count of participants with a normal atelectasis score at the indicated time point are presented here.
Outcome measures
| Measure |
Incentive Spirometer Control Arm
n=10 Participants
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
n=10 Participants
Participants using the GO2 Mouthpiece after surgery.
|
|---|---|---|
|
Number of Participants With Normal Atelectasis Score
Immediately Postoperative
|
0 Participants
|
2 Participants
|
|
Number of Participants With Normal Atelectasis Score
Postoperative Day 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Normal Atelectasis Score
Postoperative Day 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Normal Atelectasis Score
Postoperative Day 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Normal Atelectasis Score
Postoperative Day 4
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Postextubation Hours 1, 6, 12 and 24, Postoperative Days 2, 3, and 4Oxygen was provided by a nasal cannula. The flow rate of supplemental oxygen that participants required after surgery is assessed as liters per minute. Higher flow rate indicates an increased need for supplemental oxygen.
Outcome measures
| Measure |
Incentive Spirometer Control Arm
n=10 Participants
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
n=10 Participants
Participants using the GO2 Mouthpiece after surgery.
|
|---|---|---|
|
Oxygen Requirement
Postextubation Hour 6
|
2.3 liters of oxygen per minute
Standard Deviation 0.7
|
2.4 liters of oxygen per minute
Standard Deviation 0.8
|
|
Oxygen Requirement
Postextubation Hour 12
|
2.2 liters of oxygen per minute
Standard Deviation 1.5
|
2.1 liters of oxygen per minute
Standard Deviation 0.3
|
|
Oxygen Requirement
Postoperative Day 2
|
2.0 liters of oxygen per minute
Standard Deviation 1.6
|
2.3 liters of oxygen per minute
Standard Deviation 1.1
|
|
Oxygen Requirement
Postoperative Day 3
|
1.1 liters of oxygen per minute
Standard Deviation 1.2
|
1.7 liters of oxygen per minute
Standard Deviation 0.9
|
|
Oxygen Requirement
Postoperative Day 4
|
0.6 liters of oxygen per minute
Standard Deviation 1.0
|
0.5 liters of oxygen per minute
Standard Deviation 1.1
|
|
Oxygen Requirement
Postextubation Hour 1
|
3.7 liters of oxygen per minute
Standard Deviation 1.26
|
3.7 liters of oxygen per minute
Standard Deviation 1.7
|
|
Oxygen Requirement
Postextubation Hour 24
|
2.4 liters of oxygen per minute
Standard Deviation 2.8
|
2.3 liters of oxygen per minute
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Postextubation Hours 1, 6, 12 and 24Normal carbon dioxide (CO2) levels in blood range from 35.0 mmHg to 45.0 mmHg.
Outcome measures
| Measure |
Incentive Spirometer Control Arm
n=10 Participants
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
n=10 Participants
Participants using the GO2 Mouthpiece after surgery.
|
|---|---|---|
|
Carbon Dioxide Level
Postextubation Hour 12
|
37.3 mmHg
Standard Deviation 5.1
|
36.9 mmHg
Standard Deviation 4.2
|
|
Carbon Dioxide Level
Postextubation Hour 1
|
38.2 mmHg
Standard Deviation 2.9
|
39 mmHg
Standard Deviation 3.3
|
|
Carbon Dioxide Level
Postextubation Hour 6
|
37.0 mmHg
Standard Deviation 4.8
|
37.2 mmHg
Standard Deviation 4.4
|
|
Carbon Dioxide Level
Postextubation Hour 24
|
36.8 mmHg
Standard Deviation 5.1
|
38.1 mmHg
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Preoperative and postoperative day 3Forced expiratory volume in one second (FEV1) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FEV1 is the amount of air forced from lungs in one second. To describe severity of pulmonary disease, FEV1 can be expressed as a percentage of the predicted value. Values 80% and and greater of the predicted value are considered normal.
Outcome measures
| Measure |
Incentive Spirometer Control Arm
n=10 Participants
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
n=10 Participants
Participants using the GO2 Mouthpiece after surgery.
|
|---|---|---|
|
FEV1
Preoperative
|
86.4 percentage of the predicted FEV1 value
Standard Deviation 10.1
|
93.7 percentage of the predicted FEV1 value
Standard Deviation 8.9
|
|
FEV1
Postoperative Day 3
|
35.9 percentage of the predicted FEV1 value
Standard Deviation 8.0
|
43.1 percentage of the predicted FEV1 value
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Preoperative, Postoperative Day 3Forced vital capacity (FVC) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FVC is the total amount of air exhaled during the FEV test. FVC can be expressed as a percentage of the predicted value.The normal range for the percent of the predicted value is between 80% and 120%.
Outcome measures
| Measure |
Incentive Spirometer Control Arm
n=10 Participants
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
n=10 Participants
Participants using the GO2 Mouthpiece after surgery.
|
|---|---|---|
|
Forced Vital Capacity (FVC)
Preoperative
|
85.7 percentage of the predicted FVC value
Standard Deviation 9.8
|
90.1 percentage of the predicted FVC value
Standard Deviation 8.3
|
|
Forced Vital Capacity (FVC)
Postoperative Day 3
|
38.0 percentage of the predicted FVC value
Standard Deviation 9.9
|
41.6 percentage of the predicted FVC value
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Postextubation Hours 1, 6, 12 and 24, Postoperative Days 2, 3, and 4Respiratory rate is the number of breaths taken per minute. The normal respiration rate for an adult at rest is 16 to 20 breaths per minute.
Outcome measures
| Measure |
Incentive Spirometer Control Arm
n=10 Participants
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
n=10 Participants
Participants using the GO2 Mouthpiece after surgery.
|
|---|---|---|
|
Respiratory Rate
Postoperative Day 4
|
18.0 breaths per minute
Standard Deviation 1.7
|
18.6 breaths per minute
Standard Deviation 1.3
|
|
Respiratory Rate
Postextubation Hour 1
|
21.3 breaths per minute
Standard Deviation 4.0
|
20.5 breaths per minute
Standard Deviation 5.8
|
|
Respiratory Rate
Postextubation Hour 6
|
21.2 breaths per minute
Standard Deviation 5.5
|
17.9 breaths per minute
Standard Deviation 4.8
|
|
Respiratory Rate
Postextubation Hour 12
|
21.0 breaths per minute
Standard Deviation 3.9
|
19.2 breaths per minute
Standard Deviation 3.3
|
|
Respiratory Rate
Postextubation Hour 24
|
20.7 breaths per minute
Standard Deviation 3.8
|
18.9 breaths per minute
Standard Deviation 3.2
|
|
Respiratory Rate
Postoperative Day 2
|
21.7 breaths per minute
Standard Deviation 4.9
|
20.6 breaths per minute
Standard Deviation 3.4
|
|
Respiratory Rate
Postoperative Day 3
|
18.4 breaths per minute
Standard Deviation 1.3
|
18.4 breaths per minute
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Immediately Postoperative, Postoperative Day 1, 2, 3, 4Measure of heat associated with the metabolism of the body. Normal range is between 36.5-37.5 degrees Celsius (°C).
Outcome measures
| Measure |
Incentive Spirometer Control Arm
n=10 Participants
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
n=10 Participants
Participants using the GO2 Mouthpiece after surgery.
|
|---|---|---|
|
Body Temperature
Postoperative
|
36.8 °C
Standard Deviation 0.2
|
36.8 °C
Standard Deviation 0.3
|
|
Body Temperature
Postoperative Day 1
|
38.0 °C
Standard Deviation 1.4
|
37.7 °C
Standard Deviation 0.4
|
|
Body Temperature
Postoperative Day 2
|
37.5 °C
Standard Deviation 0.4
|
37.4 °C
Standard Deviation 0.3
|
|
Body Temperature
Postoperative Day 3
|
37.3 °C
Standard Deviation 0.3
|
37.4 °C
Standard Deviation 0.3
|
|
Body Temperature
Postoperative Day 4
|
37.2 °C
Standard Deviation 0.2
|
37.2 °C
Standard Deviation 0.2
|
Adverse Events
Control Arm
GO2 Mouthpiece
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Arm
n=10 participants at risk
Participants using the incentive spirometer after surgery.
|
GO2 Mouthpiece
n=10 participants at risk
Participants using the GO2 Mouthpiece after surgery.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Increased oxygen requirement 10%
|
10.0%
1/10 • Information on adverse events was collected beginning at the initial postoperative assessment and was collected through postoperative day 4.
|
0.00%
0/10 • Information on adverse events was collected beginning at the initial postoperative assessment and was collected through postoperative day 4.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place