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PEICU: Prevalence of Pulmonary Embolism in ICU

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT01457963
Collaborator
(none)
176
Enrollment
1
Location
16
Duration (Months)
11
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    176 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pulmonary Embolism in Mechanically Ventilated Patients Requiring Computed Tomography: Prevalence, Risk Factors and Outcome
    Study Start Date :
    Dec 1, 2009
    Actual Primary Completion Date :
    Apr 1, 2011
    Actual Study Completion Date :
    Apr 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    pulmonary embolism, deep venous thrombosis

    Outcome Measures

    Primary Outcome Measures

    1. Find a pulmonary embolism on the CT scan [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.

    Secondary Outcome Measures

    1. To find thrombus on compression ultrasound (CUS) of the four limbs [CUS within 48 hours after the CT scan]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital of grenoble Grenoble France 38043

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT01457963
    Other Study ID Numbers:
    • 5891
    First Posted:
    Oct 24, 2011
    Last Update Posted:
    Oct 24, 2011
    Last Verified:
    Oct 1, 2011
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Thrombosis
    Embolism
    Venous Thrombosis

    Study Results

    No Results Posted as of Oct 24, 2011