Trial Outcomes & Findings for Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery (NCT NCT03438383)
NCT ID: NCT03438383
Last Updated: 2020-12-16
Results Overview
difference in FEV1 value measured by spirometry pre- and post-operatively
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
24 h before surgery and at 24, 48 and 72 h post-operatively
Results posted on
2020-12-16
Participant Flow
Τhis prospective randomized single-blinded study with a control group was conducted in a tertiary urban Greek hospital. Subjects recruitment was performed at the respective departments of obesity surgery where subjects underwent surgery, also belonging to tertiary hospitals.
Exclusion criteria included cardiovascular and pulmonary disease not related to obesity status, and chronic renal disease. From the 48 patients initially enrolled in the study, 1 was excluded from the participant flow because of recent onset of cardiovascular disease. 47 patients were assigned to the study groups.
Participant milestones
| Measure |
Sham Bi-PAP
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 centimeters of water (cm H2O).
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of oxygen saturation by pulse oximetry (SpO2), PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as chronic obstructive pulmonary disease (COPD), respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
14
|
21
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
Sham Bi-PAP
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 centimeters of water (cm H2O).
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of oxygen saturation by pulse oximetry (SpO2), PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as chronic obstructive pulmonary disease (COPD), respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
9
|
3
|
Baseline Characteristics
Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery
Baseline characteristics by cohort
| Measure |
Sham Bi-PAP
n=14 Participants
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
n=21 Participants
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 8 • n=5 Participants
|
31 years
STANDARD_DEVIATION 6 • n=7 Participants
|
31.8 years
STANDARD_DEVIATION 6.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 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
Greece
|
14 participants
n=5 Participants
|
21 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Height
|
171 Centimeters
STANDARD_DEVIATION 7 • n=5 Participants
|
172 Centimeters
STANDARD_DEVIATION 27 • n=7 Participants
|
171.6 Centimeters
STANDARD_DEVIATION 21.16 • n=5 Participants
|
|
Weight
|
151 Kilograms
STANDARD_DEVIATION 30 • n=5 Participants
|
157 Kilograms
STANDARD_DEVIATION 27 • n=7 Participants
|
154.6 Kilograms
STANDARD_DEVIATION 27.96 • n=5 Participants
|
|
Body mass index-BMI
|
52 Kilograms/squared meters
STANDARD_DEVIATION 6 • n=5 Participants
|
53 Kilograms/squared meters
STANDARD_DEVIATION 8 • n=7 Participants
|
52.6 Kilograms/squared meters
STANDARD_DEVIATION 7.19 • n=5 Participants
|
|
Smoking
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Type of open bariatric surgery (OBS): gastroplasty
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Type of OBS: open gastric bypass
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 h before surgery and at 24, 48 and 72 h post-operativelydifference in FEV1 value measured by spirometry pre- and post-operatively
Outcome measures
| Measure |
Sham Bi-PAP
n=14 Participants
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
n=21 Participants
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
|---|---|---|
|
Forced Expiratory Volume at One Second (FEV1) Difference
24h before surgery
|
3.1 Litres
Standard Deviation 0.7
|
3.1 Litres
Standard Deviation 0.6
|
|
Forced Expiratory Volume at One Second (FEV1) Difference
24h post-op
|
1.3 Litres
Standard Deviation 0.5
|
1.4 Litres
Standard Deviation 0.3
|
|
Forced Expiratory Volume at One Second (FEV1) Difference
48h post-op
|
1.3 Litres
Standard Deviation 0.4
|
1.7 Litres
Standard Deviation 0.4
|
|
Forced Expiratory Volume at One Second (FEV1) Difference
72h post-op
|
1.4 Litres
Standard Deviation 0.5
|
1.9 Litres
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: 24 h before surgery and at 24, 48 and 72 hours post-operativelydifference in FVC value measured by spirometry pre- and post-operatively
Outcome measures
| Measure |
Sham Bi-PAP
n=14 Participants
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
n=21 Participants
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
|---|---|---|
|
Forced Vital Capacity (FVC) Difference
24h before surgery
|
3.4 Litres
Standard Deviation 1.0
|
3.5 Litres
Standard Deviation 0.7
|
|
Forced Vital Capacity (FVC) Difference
24h post-op
|
1.3 Litres
Standard Deviation 0.4
|
1.6 Litres
Standard Deviation 0.4
|
|
Forced Vital Capacity (FVC) Difference
48h post-op
|
1.5 Litres
Standard Deviation 0.5
|
2.0 Litres
Standard Deviation 0.4
|
|
Forced Vital Capacity (FVC) Difference
72h post-op
|
1.9 Litres
Standard Deviation 0.6
|
2.3 Litres
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: 24 h before surgery and at 24, 48 and 72 hours post-operativelydifference in PEFR value measured by spirometry pre- and post-operatively
Outcome measures
| Measure |
Sham Bi-PAP
n=14 Participants
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
n=21 Participants
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) Difference
24h before surgery
|
376.9 Litres/minute
Standard Deviation 71.7
|
325.3 Litres/minute
Standard Deviation 75.2
|
|
Peak Expiratory Flow Rate (PEFR) Difference
24h post-op
|
146.9 Litres/minute
Standard Deviation 61.4
|
137.4 Litres/minute
Standard Deviation 30.5
|
|
Peak Expiratory Flow Rate (PEFR) Difference
48h post-op
|
166.0 Litres/minute
Standard Deviation 68.1
|
195.7 Litres/minute
Standard Deviation 46.0
|
|
Peak Expiratory Flow Rate (PEFR) Difference
72h post-op
|
190.1 Litres/minute
Standard Deviation 64.2
|
247.5 Litres/minute
Standard Deviation 60.5
|
PRIMARY outcome
Timeframe: 24 h before surgery and at 24, 48 and 72 hours post-operativelydifference in SpO2 value measured by spirometry pre- and post-operatively
Outcome measures
| Measure |
Sham Bi-PAP
n=14 Participants
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
n=21 Participants
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
|---|---|---|
|
SpO2 Difference
24h before surgery
|
96.9 percentage of SpO2
Standard Deviation 0.7
|
96.9 percentage of SpO2
Standard Deviation 1.1
|
|
SpO2 Difference
24h post-op
|
91.6 percentage of SpO2
Standard Deviation 3.5
|
92.6 percentage of SpO2
Standard Deviation 3.2
|
|
SpO2 Difference
48h post-op
|
92.4 percentage of SpO2
Standard Deviation 3.5
|
95.2 percentage of SpO2
Standard Deviation 1.9
|
|
SpO2 Difference
72h post-op
|
92.5 percentage of SpO2
Standard Deviation 3.7
|
96.8 percentage of SpO2
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: At 24, 48 and 72 hours post-operativelyoccurrence of hypoxemia, considered as SpO2\<90%, post-operatively
Outcome measures
| Measure |
Sham Bi-PAP
n=14 Participants
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
n=21 Participants
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
|---|---|---|
|
Number of Participants With Hypoxemia
48h post-op
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hypoxemia
24h post-op
|
5 Participants
|
0 Participants
|
|
Number of Participants With Hypoxemia
72h post-op
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At 24, 48 and 72 hours post-operativelyoccurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline
Outcome measures
| Measure |
Sham Bi-PAP
n=14 Participants
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
n=21 Participants
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
|---|---|---|
|
Number of Participants With Atelectasis
24h post-op
|
3 Participants
|
0 Participants
|
|
Number of Participants With Atelectasis
48h list-op
|
3 Participants
|
0 Participants
|
|
Number of Participants With Atelectasis
72h post-op
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: right before spirometry, at 24, 48 and 72 h post-operativelyIntensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)
Outcome measures
| Measure |
Sham Bi-PAP
n=14 Participants
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
n=21 Participants
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
|---|---|---|
|
Post-operative Pain
24h post-op
|
6.5 score on a scale
Standard Deviation 1.9
|
6.5 score on a scale
Standard Deviation 1.3
|
|
Post-operative Pain
48h post-op
|
4.5 score on a scale
Standard Deviation 1.5
|
5.3 score on a scale
Standard Deviation 1.9
|
|
Post-operative Pain
72h post-op
|
3.3 score on a scale
Standard Deviation 1.2
|
3.5 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: From day of admission to day of discharge from the hospitalPopulation: Overall number of patients analyzed in each group is the sum of participants who underwent gastroplasty and those who underwent open gastric bypass (11+3=14 for the Sham Bi-PAP group and 15+6=21 for the Bi-PAP group).
duration of hospitalization, calculated by discharge date minus admission date
Outcome measures
| Measure |
Sham Bi-PAP
n=14 Participants
Sham Bi-PAP was applied through nasal mask for 3 days postoperatively. Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of Bi-PAP. With this modality, also used on previous studies, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
Sham Bi-PAP: Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.
|
Bi-PAP
n=21 Participants
Bi-PAP through nasal mask, at individualized IPAP/EPAP pressures, was applied for 3 days postoperatively. IPAP and EPAP in the Bi-PAP system were individualized for each patient in accordance with accepted values of SpO2, PaCO2, and patient synchronization and tolerability with the device.Individualized setting of pressures in patient group was applied gradually starting with 12/4 cm H2O (IPAP/EPAP) and up to 18/10 (IPAP/EPAP) with consecutive increases of 2 cm H2O.
Bi-PAP: The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
|
|---|---|---|
|
Days of Hospitalization
Type of OBS: gastroplasty
|
6 days
Interval 5.0 to 7.0
|
6 days
Interval 5.0 to 7.0
|
|
Days of Hospitalization
Type of OBS: open gastric bypass
|
10 days
Interval 9.0 to 11.0
|
10 days
Interval 9.0 to 11.0
|
Adverse Events
Sham Bi-PAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bi-PAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Konstantinos Roditis, Study Chair
Department of Vascular Surgery, Korgialeneio-Benakeio Hellenic Red Cross Hospital, Athens, Greece
Phone: +306976686951
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place