The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure

Critically Ill Patients Clinical Trial

Official title:

The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143494
• Other study ID #: 1200
• Status: Completed
• Phase: N/A
• First received: September 1, 2005
• Last updated: September 24, 2008
• Start date: July 2005
• Est. completion date: November 2007

Study information

• Verified date: September 2008
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The investigators aim to compare the bladder pressure to the gastric pressure in critically ill patients.

Description:

In critically ill patients, we will measure the gastric pressure by a gastric balloon and the bladder pressure by the intra-vesical pressure to find the optimal method to estimate the abdominal pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 90 Years

Eligibility

Inclusion Criteria:

• Critically ill patients during invasive mechanical ventilation

Exclusion Criteria:

• Contraindication to measure the bladder pressure

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients

Intervention

Procedure:
• measurement of abdominal pressure
measurement of abdominal pressure with different volume and saline temperature

Locations

Country	Name	City	State
Italy	Policlinico Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Chiumello D, Tallarini F, Chierichetti M, Polli F, Li Bassi G, Motta G, Azzari S, Carsenzola C, Gattinoni L. The effect of different volumes and temperatures of saline on the bladder pressure measurement in critically ill patients. Crit Care. 2007;11(4):R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the bladder pressure		5 minutes	No