NCT00143494

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

2.3 years

First QC Date

September 1, 2005

Last Update Submit

September 24, 2008

Conditions

Critically Ill Patients

Outcome Measures

Primary Outcomes (1)

  • To estimate the bladder pressure

    5 minutes

Study Arms (1)

1

EXPERIMENTAL

Critically hill, mechanically ventilated patients

Procedure: measurement of abdominal pressure

Interventions

measurement of abdominal pressurePROCEDURE

measurement of abdominal pressure with different volume and saline temperature

1

Eligibility Criteria

Age16 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Critically ill patients during invasive mechanical ventilation

You may not qualify if:

  • Contraindication to measure the bladder pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Hospital

Milan, 20100, Italy

Location

Related 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):R82. doi: 10.1186/cc6080.

    PMID: 17655744RESULT

Study Officials

  • davide chiumello, MD

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

July 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

IT(1)