Prevalence of Pulmonary Embolism in ICU (PEICU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01457963
First received: October 20, 2011
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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
Pulmonary Embolism
Deep Venous Thrombosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Embolism in Mechanically Ventilated Patients Requiring Computed Tomography: Prevalence, Risk Factors and Outcome

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Find a pulmonary embolism on the CT scan [ Time Frame: CT scan at the day of inclusion ] [ Designated as safety issue: No ]
    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:
  • To find thrombus on compression ultrasound (CUS) of the four limbs [ Time Frame: CUS within 48 hours after the CT scan ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: December 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
pulmonary embolism, deep venous thrombosis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01457963

Locations
France
University hospital of grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean Francois TIMSIT, PU/PH University Hospital, Grenoble
  More Information

No publications provided by University Hospital, Grenoble

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01457963     History of Changes
Other Study ID Numbers: 5891
Study First Received: October 20, 2011
Last Updated: October 21, 2011
Health Authority: France: Institutional Ethical Committee
France: The Commission nationale de l’informatique et des libertés

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism

ClinicalTrials.gov processed this record on September 15, 2014