Prevalence of Pulmonary Embolism in ICU

Pulmonary Embolism Clinical Trial

— PEICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457963
• Other study ID #: 5891
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: October 21, 2011
• Start date: December 2009
• Est. completion date: April 2011

Study information

• Verified date: October 2011
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical CommitteeFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Embolism
• Pulmonary Embolism
• Venous Thrombosis

Locations

Country	Name	City	State
France	University hospital of grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Find a pulmonary embolism on the CT scan	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	No
Secondary	To find thrombus on compression ultrasound (CUS) of the four limbs		CUS within 48 hours after the CT scan	No