Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity

Morbid Obesity Clinical Trial

Official title:

Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481880
• Other study ID #: Rambam ethics number: 0019-12
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The correlations between gastric and urinary bladder pressures with Intra-abdominal pewssure have not been addressed

Description:

Intra-abdominal pressure (IAP) affects cardio-respiratory hemodynamics and can be assessed either directly, or by measuring gastric or urinary bladder pressure. However, in patients with morbid obesity, the correlations between gastric and urinary bladder pressures with IAP have not been addressed. The investigator's aim was to assess the correlations between IAP and gastric and urinary bladder pressure in patients with morbid obesity, at normal and elevated levels of IAP, and to examine the effects of increasing IAP and patient position on hemodynamic and respiratory parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 1, 2020
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age >18 years

• Morbid Obesity

• candidate for bariatric surgery

Exclusion Criteria:

• Contraindication to laparoscopy

• Advanced COPD

• Advanced CHF

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Intra-Abdominal Hypertension
• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Diagnostic Test:
• measuring IAP and respiratory parameters
Effect of IAP on respiratory parameters Correlation between IAP and Gastric and urinary bladder pressures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between intra-abdominal pressure and gastric pressure	different measurement methods	Early post-operative- up to 1 week post operation
Primary	Intra-abdominal pressure	Correlation between measured IAP according to different measurement methods	0-7 days post bariatric surgery