UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057323 |
|---|---|
| Receipt number | R000065523 |
| Scientific Title | Driving Pressure and Postoperative SaFi Index in Bariatric Surgery: Robot-Assisted vs Laparoscopic Approaches. A Retrospective Cohort Study |
| Date of disclosure of the study information | 2025/03/20 |
| Last modified on | 2025/03/18 13:12:29 |
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Basic information
Public title
Driving Pressure and Postoperative SaFi Index in Bariatric Surgery: Robot-Assisted vs Laparoscopic Approaches. A Retrospective Cohort Study
Acronym
DriPSI-Bari Study
Scientific Title
Driving Pressure and Postoperative SaFi Index in Bariatric Surgery: Robot-Assisted vs Laparoscopic Approaches. A Retrospective Cohort Study
Scientific Title:Acronym
DriPSI-Bari Study
Region
| North America |
Condition
Condition
Obesity in patients undergoing laparoscopic or robot-assisted bariatric surgery
Classification by specialty
| Anesthesiology | Operative medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify the optimal cutoff point for driving pressure that is associated with improved postoperative oxygenation (SaFi index) in obese patients undergoing laparoscopic or robot-assisted bariatric surgery under general anesthesia. By analyzing respiratory mechanics, this research seeks to provide insights into lung-protective ventilation strategies in this population
Basic objectives2
Others
Basic objectives -Others
To optimize intraoperative ventilatory strategies by determining the best driving pressure threshold associated with improved postoperative oxygenation (SaFi index) in obese patients undergoing laparoscopic or robot-assisted bariatric surgery
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Optimal driving pressure threshold associated with an improved postoperative Sa/Fi index in obese patients undergoing laparoscopic or robot-assisted bariatric surgery
Key secondary outcomes
1. To analyze the association between transanesthetic driving pressure and postoperative SaFi in obese patients, stratifying the analysis by type of bariatric surgery (laparoscopic or robotic).
2. To analyze the association between transanesthetic driving pressure and postoperative SaFi in obese patients postoperative bariatric surgery (laparoscopic or robotic), stratifying the analysis based on the body mass index (grade I obesity, grade II obesity, and morbidity).
3. To analyze the association between transanesthetic driving pressure in obese patients postoperative bariatric surgery (laparoscopic or robotic) and time to discharge from the postanesthesia care unit.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.- Patients over 18 years of age
2.- Patients of both genders
3.- Patients diagnosed with BMI > 30 kg/m2
4.- Patients admitted to Bariatric surgery
5.- Complete file
Key exclusion criteria
1.- Files with incomplete data
2.- File with a voluntary discharge form or transfer note
3.- Patients who need to be intubated in intensive care after surgery
Target sample size
111
Research contact person
Name of lead principal investigator
| 1st name | Manuel |
| Middle name | |
| Last name | Guerrero |
Organization
Hospital de Prado Medical Center
Division name
Department of Bariatric Anesthesiology
Zip code
22105
Address
Bugambilias #50, Fraccionamiento el Prado, Tijuana Baja California
TEL
+526642746273
manuelguerreromd@gmail.com
Public contact
Name of contact person
| 1st name | Diego |
| Middle name | |
| Last name | Escarraman |
Organization
Instituto Mexicano del Seguro Social
Division name
Anesthesiology deparment
Zip code
02990
Address
Paseo de las Jacarandas sin numero, Colonia La Raza, Azcapotzalco, Ciudad de Mexico
TEL
+525570778209
Homepage URL
diego-piloto@hotmail.com
Sponsor or person
Institute
Hospital de Prado Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical teaching and research, Hospital de Prado Medical Center
Address
Bugambilias #50, Fraccionamiento el Prado, Tijuana Baja California
Tel
+528114837002
arellanespaloma@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective cohort study based on the analysis of electronic medical records from patients who underwent bariatric surgery (laparoscopic or robot-assisted). The study compares intraoperative driving pressure and its correlation with the postoperative SaFi index. Data were collected from hospital databases without any direct patient intervention. The analysis will stratify patients based on the type of surgical approach and BMI categories
Management information
Registered date
| 2025 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065523
