The Estimation of Abdominal Pressure by the Bladder and G... | NCT00143494

Studies
The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure

NCT00143494

Sponsor

Policlinico Hospital

Status

Completed

Last Update Posted

Sep 25, 2008Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Critically Ill Patients

Interventions

measurement of abdominal pressure

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 1, 2005

First Posted Date

Sep 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2008

Last Update Posted Date

Sep 25, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Critically hill, mechanically ventilated patients	Procedure: measurement of abdominal pressure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
measurement of abdominal pressure	Procedure	measurement of abdominal pressure with different volume and saline temperature	1

Measure	Description	Time Frame
To estimate the bladder pressure		5 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Critically ill patients during invasive mechanical ventilation

Exclusion Criteria:

Contraindication to measure the bladder pressure

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
davide chiumello, MD	Policlinico Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico Hospital		Milan		20100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17655744	Result	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.