Pulmonary EmbolismPEICUNCT01457963
Prevalence of Pulmonary Embolism in ICU
An observational study of Pulmonary Embolism and Deep Venous Thrombosis, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Deep Venous Thrombosis
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in ICU, mecanically ventilated with a CT scab with iodine injection
Who may be able to join
- all patients requiring invasive MV and thoracic contrast-enhanced CT for any reason
Who cannot join
- a diagnosis of PE before ICU admission,
- allergy to contrast agents,
- and age younger than 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Embolism, Deep Venous Thrombosis
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pulmonary embolism, deep venous thrombosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: CT scan at the day of inclusion
Secondary outcomes (1)
To find thrombus on compression ultrasound (CUS) of the four limbs
Measured: CUS within 48 hours after the CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startDec 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Francois TIMSIT, PU/PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457963
- Sponsor's protocol ID
- 5891
- Acronym
- PEICU
- Status last verified
- Oct 2011
- First submitted
- 20 Oct 2011
- Last updated
- 24 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Minet C, Lugosi M, Savoye PY, Menez C, Ruckly S, Bonadona A, Schwebel C, Hamidfar-Roy R, Dumanoir P, Ara-Somohano C, Ferretti GR, Timsit JF. Pulmonary embolism in mechanically ventilated patients requiring computed tomography: Prevalence, risk factors, and outcome. Crit Care Med. 2012 Dec;40(12):3202-8. doi: 10.1097/CCM.0b013e318265e461.
PubMed 23164766
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Embolism in Mechanically Ventilated Patients Requiring Computed Tomography: Prevalence, Risk Factors and Outcome
- ClinicalTrials.gov ID
- NCT01457963
- Acronym / sponsor ID
- PEICU / 5891
- Conditions
- Pulmonary Embolism, Deep Venous Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary embolism, deep venous thrombosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in ICU, mecanically ventilated with a CT scab with iodine injection
Key inclusion criteria (1 listed)
- all patients requiring invasive MV and thoracic contrast-enhanced CT for any reason
Key exclusion criteria (3 listed)
- a diagnosis of PE before ICU admission,
- allergy to contrast agents,
- and age younger than 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
To find thrombus on compression ultrasound (CUS) of the four limbs
Time frame: CUS within 48 hours after the CT scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
- Derived from this study: PubMed 23164766Minet C, Lugosi M, Savoye PY, Menez C, Ruckly S, Bonadona A, Schwebel C, Hamidfar-Roy R, Dumanoir P, Ara-Somohano C, Ferretti GR, Timsit JF. Pulmonary embolism in mechanically ventilated patients requiring computed tomography: Prevalence, risk factors, and outcome. Crit Care Med. 2012 Dec;40(12):3202-8. doi: 10.1097/CCM.0b013e318265e461.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Francois TIMSIT, PU/PH principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Deep Venous Thrombosis, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Find a pulmonary embolism on the CT scan (time frame: CT scan at the day of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01457963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2011.