Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly O... | NCT03438383

Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly O... | NCT03438383 | Trialant

Sponsor/Collaborators Module

Name	Class
Elpis General Hospital	UNKNOWN
Sotiria General Hospital	OTHER
Evgenidion Hospital	UNKNOWN

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sham Bi-PAP	Sham Comparator	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 centimeter of water (cm H2O).	Device: Sham Bi-PAP
Bi-PAP	Active Comparator	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.	Device: Bi-PAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bi-PAP	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forced Expiratory Volume at One Second (FEV1) Difference	difference in FEV1 value measured by spirometry pre- and post-operatively	24 h before surgery and at 24, 48 and 72 h post-operatively
Forced Vital Capacity (FVC) Difference	difference in FVC value measured by spirometry pre- and post-operatively	24 h before surgery and at 24, 48 and 72 hours post-operatively
Peak Expiratory Flow Rate (PEFR) Difference	difference in PEFR value measured by spirometry pre- and post-operatively	24 h before surgery and at 24, 48 and 72 hours post-operatively
SpO2 Difference	difference in SpO2 value measured by spirometry pre- and post-operatively	24 h before surgery and at 24, 48 and 72 hours post-operatively
Number of Participants With Hypoxemia	occurrence of hypoxemia, considered as SpO2<90%, post-operatively	At 24, 48 and 72 hours post-operatively
Number of Participants With Atelectasis	occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline	At 24, 48 and 72 hours post-operatively

Secondary Outcomes

Measure	Description	Time Frame
Post-operative Pain	Intensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)	right before spirometry, at 24, 48 and 72 h post-operatively
Days of Hospitalization

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Konstantinos Louis, MD, PhD	Dpt of ObGyn, Konstantopoulio-Patision Hospital, Greece	Study Director
Konstantinos Roditis, MD, MSc	Dpt of Vascular Surgery, Korgialenio-Benakio HRC Hospital, Greece	Study Chair
Aikaterini N. Alexandropoulou, MD, PhD	Anaesthesiology Dpt, Evangelismos Hospital, Greece	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16779465	Background	Parameswaran K, Todd DC, Soth M. Altered respiratory physiology in obesity. Can Respir J. 2006 May-Jun;13(4):203-10. doi: 10.1155/2006/834786.
19875713	Background	Salome CM, King GG, Berend N. Physiology of obesity and effects on lung function. J Appl Physiol (1985). 2010 Jan;108(1):206-11. doi: 10.1152/japplphysiol.00694.2009. Epub 2009 Oct 29.

Label	URL
Publication of Study Results	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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 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.
BG001	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 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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00033± 8 BG00131± 6 BG00231.8± 6.83

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG00113 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Greece

Title	Measurements
	BG00014 BG00121 BG002

Height

Mean

Standard Deviation

Centimeters

Title

Denominators

Categories

Title	Measurements
	BG000171± 7 BG001172± 27 BG002

Weight

Mean

Standard Deviation

Kilograms

Title

Denominators

Categories

Title	Measurements
	BG000151± 30 BG001157± 27 BG002

Body mass index-BMI

Mean

Standard Deviation

Kilograms/squared meters

Title

Denominators

Categories

Title	Measurements
	BG00052± 6 BG00153± 8 BG002

Smoking

Whether the subject declared as an active smoker

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0007 BG00114 BG002

Type of open bariatric surgery (OBS): gastroplasty

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00011 BG00115 BG002

Type of OBS: open gastric bypass

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0004 BG0016 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Forced Expiratory Volume at One Second (FEV1) Difference

difference in FEV1 value measured by spirometry pre- and post-operatively

Posted

Mean

Standard Deviation

Litres

24 h before surgery and at 24, 48 and 72 h post-operatively

ID	Title	Description
OG000	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 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.
OG001	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 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.

Units	Counts
Participants	OG00014 OG00121

Title

Denominators

Categories

24h before surgery

Title	Measurements
	OG0003.1± 0.7 OG0013.1± 0.6

24h post-op

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	24 h before surgery (pre-operative or baseline values)	ANOVA		0.88	The a priori threshold for statistical significance was set at <0.05													Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.

Primary

Forced Vital Capacity (FVC) Difference

difference in FVC value measured by spirometry pre- and post-operatively

Posted

Mean

Standard Deviation

Litres

24 h before surgery and at 24, 48 and 72 hours post-operatively

ID	Title	Description
OG000	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 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.
OG001	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 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.

Primary

Peak Expiratory Flow Rate (PEFR) Difference

difference in PEFR value measured by spirometry pre- and post-operatively

Posted

Mean

Standard Deviation

Litres/minute

24 h before surgery and at 24, 48 and 72 hours post-operatively

ID	Title	Description
OG000	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 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.
OG001	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 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.

Primary

SpO2 Difference

difference in SpO2 value measured by spirometry pre- and post-operatively

Posted

Mean

Standard Deviation

percentage of SpO2

24 h before surgery and at 24, 48 and 72 hours post-operatively

ID	Title	Description
OG000	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 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.
OG001	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 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.

Primary

Number of Participants With Hypoxemia

occurrence of hypoxemia, considered as SpO2<90%, post-operatively

Posted

Count of Participants

Participants

At 24, 48 and 72 hours post-operatively

ID	Title	Description
OG000	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 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.
OG001	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 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.

Primary

Number of Participants With Atelectasis

occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline

Posted

Count of Participants

Participants

At 24, 48 and 72 hours post-operatively

ID	Title	Description
OG000	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 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.
OG001	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 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.

Secondary

Post-operative Pain

Intensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)

Posted

Mean

Standard Deviation

score on a scale

right before spirometry, at 24, 48 and 72 h post-operatively

ID	Title	Description
OG000	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 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.
OG001	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 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.

Secondary

Days of Hospitalization

duration of hospitalization, calculated by discharge date minus admission date

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).

Posted

Mean

Full Range

days

From day of admission to day of discharge from the hospital

ID	Title	Description
OG000	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 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.
OG001	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 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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 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.	0	14	0	14	0	14
EG001	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 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.	0	21	0	21	0	21

Point of Contact

Title	Organization	Phone	Extension	Email
Dr. Konstantinos Roditis, Study Chair	Department of Vascular Surgery, Korgialeneio-Benakeio Hellenic Red Cross Hospital, Athens, Greece	+306976686951		roditis.k@gmail.com

ID	Term
D001261	Pulmonary Atelectasis
D029424	Pulmonary Disease, Chronic Obstructive
D008171	Lung Diseases
D012131	Respiratory Insufficiency
D000860	Hypoxia
D009767	Obesity, Morbid
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012120	Respiration Disorders
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Title

Denominators

Categories

24h before surgery

Title	Measurements
	OG0003.4± 1.0 OG0013.5± 0.7

24h post-op

Title	Measurements
	OG0001.3± 0.4 OG0011.6± 0.4

48h post-op

Title	Measurements
	OG0001.5± 0.5 OG0012.0± 0.4

72h post-op

Title	Measurements
	OG0001.9± 0.6 OG0012.3± 0.4

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	24 h before surgery (pre-operative or baseline values)	ANOVA	0.75	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.
OG000 OG001	24 h post-operatively	ANOVA	0.09	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.
OG000 OG001	48 h post-operatively	ANOVA	0.008	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.
OG000 OG001	72 h post-operatively	ANOVA	0.013	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.

Title

Denominators

Categories

24h before surgery

Title	Measurements
	OG000376.9± 71.7 OG001325.3± 75.2

24h post-op

Title	Measurements
	OG000146.9± 61.4 OG001137.4± 30.5

48h post-op

Title	Measurements
	OG000166.0± 68.1 OG001195.7± 46.0

72h post-op

Title	Measurements
	OG000190.1± 64.2 OG001247.5± 60.5

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	24 h before surgery (pre-operative or baseline values)	ANOVA	0.05	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.
OG000 OG001	24 h post-operatively	ANOVA	0.55	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.
OG000 OG001	48h post-operatively	ANOVA	0.13	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.
OG000 OG001	72 h post-operatively	ANOVA	0.011	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.

Title

Denominators

Categories

24h before surgery

Title	Measurements
	OG00096.9± 0.7 OG00196.9± 1.1

24h post-op

Title	Measurements
	OG00091.6± 3.5 OG00192.6± 3.2

48h post-op

Title	Measurements
	OG00092.4± 3.5 OG00195.2± 1.9

72h post-op

Title	Measurements
	OG00092.5± 3.7 OG00196.8± 1.0

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	24 h before surgery (pre-operative or baseline values)	ANOVA	0.83	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.
OG000 OG001	24 h post-operatively	ANOVA	0.37	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.
OG000 OG001	48 h post-operatively	ANOVA	0.0035	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.
OG000 OG001	72 h post-operatively	ANOVA	0.000015	The a priori threshold for statistical significance was set at <0.05	Superiority	We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.

Title

Denominators

Categories

Type of OBS: gastroplasty

- ParticipantsOG00011
- ParticipantsOG00115

Title	Measurements
	OG0006(5 to 7) OG0016(5 to 7)

Type of OBS: open gastric bypass

- ParticipantsOG0003
- ParticipantsOG0016

Title	Measurements
	OG00010(9 to 11) OG001