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The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure

Primary Purpose

Critically Ill Patients

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

measurement of abdominal pressure

About this trial

This is an interventional diagnostic trial for Critically Ill Patients

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Critically ill patients during invasive mechanical ventilation Exclusion Criteria: Contraindication to measure the bladder pressure

Sites / Locations

Policlinico Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Critically hill, mechanically ventilated patients

Outcomes

Primary Outcome Measures

To estimate the bladder pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT00143494

First Posted

September 1, 2005

Last Updated

September 24, 2008

Sponsor

Policlinico Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00143494

Brief Title

The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure

Official Title

The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Policlinico Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critically Ill Patients

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Critically hill, mechanically ventilated patients

Intervention Type

Procedure

Intervention Name(s)

measurement of abdominal pressure

Intervention Description

measurement of abdominal pressure with different volume and saline temperature

Primary Outcome Measure Information:

Title

To estimate the bladder pressure

Time Frame

5 minutes

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Critically ill patients during invasive mechanical ventilation Exclusion Criteria: Contraindication to measure the bladder pressure

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

davide chiumello, MD

Organizational Affiliation

Policlinico Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Policlinico Hospital

City

Milano

ZIP/Postal Code

20100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

17655744

Citation

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):R82. doi: 10.1186/cc6080.

Results Reference

result

Learn more about this trial

The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure

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