Prevalence of Pulmonary Embolism in ICU (PEICU)

October 21, 2011 updated by: University Hospital, Grenoble

Pulmonary Embolism in Mechanically Ventilated Patients Requiring Computed Tomography: Prevalence, Risk Factors and Outcome

The primary objective of this study was to estimate the prevalence of PE among consecutive ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent injection, regardless of whether PE was suspected clinically. The secondary objectives were to assess the association between PE and DVT, to identify risk factors for VTE, and to determine the outcome of VTE.

Study Overview

Status

Completed

Detailed Description

Background: Pulmonary embolism (PE) produces nonspecific or minimal symptoms in mechanically ventilated (MV) patients, leading to underdiagnosis. We estimated the prevalence of PE and associations with deep vein thrombosis (DVT) among MV patients.

Methods: Consecutive MV patients who required thoracic computed tomography (CT) in a single ICU. Compression ultrasound of the four limbs was performed within 48 hours of inclusion. Curative anticoagulation therapy was given immediately after PE diagnosis.

Study Type

Observational

Enrollment (Actual)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Grenoble, France, 38043
        • University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in ICU, mecanically ventilated with a CT scab with iodine injection

Description

Inclusion Criteria:

  • all patients requiring invasive MV and thoracic contrast-enhanced CT for any reason

Exclusion Criteria:

  • a diagnosis of PE before ICU admission,
  • allergy to contrast agents,
  • and age younger than 18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
pulmonary embolism, deep venous thrombosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Find a pulmonary embolism on the CT scan
Time Frame: CT scan at the day of inclusion
TO estimate the prevalence of PE among consecutive ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent injection, regardless of whether PE was suspected clinically.
CT scan at the day of inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
To find thrombus on compression ultrasound (CUS) of the four limbs
Time Frame: CUS within 48 hours after the CT scan
CUS within 48 hours after the CT scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jean Francois TIMSIT, PU/PH, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

October 21, 2011

First Posted (Estimate)

October 24, 2011

Study Record Updates

Last Update Posted (Estimate)

October 24, 2011

Last Update Submitted That Met QC Criteria

October 21, 2011

Last Verified

October 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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