Adult Patients Ventilated More Than 48 hPULCONCT01098773
Pulmonary and Cardiac Ultrasound During Weaning From Mechanical Ventilation
An observational study of Adult Patients Ventilated More Than 48 h and Stable Respiratory and Hemodynamic Conditions for SBT, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Prospective observational clinical multicentric study in ICU with ventilated patients requiring chest ultrasound analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients Ventilated More Than 48 h, Stable Respiratory and Hemodynamic Conditions for SBT, Consent of Patients
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Dec 2010
- 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: Prospective observational clinical multicentric study on ICU ventilated patients requiring chest ultrasound analysis during weaning from mechanical ventilation with 48 hours of follow-up. Studying variations of cardiac markers
Who may be able to join
- Adult patients ventilated more than 48 h
- Stable respiratory and hemodynamic conditions for SBT
- Consent of patients
- Arterial line
Who cannot join
- Laryngeal dyspnea
- Tracheostomy
- Arythmya
- No echogenicity
- Paraplegia >T8
Trial locations and contacts
1 site in 1 country.
About this study
Prospective observational clinical multicentric study in ICU with ventilated patients requiring chest ultrasound analysis.
Read the detailed description
Prospective observational clinical multicentric study on ICU ventilated patients requiring chest ultrasound analysis during weaning from mechanical ventilation with 48 hours of follow-up. Studying variations of cardiac markers
- Conditions
- Adult Patients Ventilated More Than 48 h, Stable Respiratory and Hemodynamic Conditions for SBT, Consent of Patients, Arterial Line
- Keywords
- Weaning from mechanical ventilation, BNP, Lung ultrasound, Echocardiography
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 |
|---|---|---|
| patients requiring ventilation | Not described | |
| patients who weaned permanently | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the change in pulmonary aeration during the test of weaning from mechanical ventilation (before, at the end, and 4-6 h after) between patients requiring re-ventilation before the 48th hour, and those weaned permanently.
Compare the change in pulmonary aeration during the test of weaning from mechanical ventilation (before, at the end, and 4-6 h after) between patients requiring re-ventilation before the 48th hour, and those weaned permanently.
Measured: before, at the end, and 4-6 h after
Secondary outcomes (6)
Studying variations, during weaning from mechanical ventilation, of pressure of left ventricle filling (E / Ea) coupled with those of plasma BNP.
Studying variations, during weaning from mechanical ventilation, of pressure of left ventricle filling (E / Ea) coupled with those of plasma BNP.
Measured: in the 4-6 early hours
Assessing the effects of E / Ea and BNP variations on the success or failure in the 4-6 early hours.
Assessing the effects of E / Ea and BNP variations on the success or failure in the 4-6 early hours.
Measured: in the 4-6 early hours.
Compare the variations of lung ultrasound score during the test of the weaning from mechanical ventilation between patients failed the spontaneous breathing test (SBT) and those extubated after successful SBT.
Compare the variations of lung ultrasound score during the test of the weaning from mechanical ventilation between patients failed the spontaneous breathing test (SBT) and those extubated after successful SBT.
Measured: in the 4-6 early hours
Comparison of levels epithelial and endothelial markers
Measured: at h0, h1, h4, h6
Constitution serum bank for epithelial (sRAGE) markers dosages
Measured: at h0, h1, h4, h6
constitution serum bank for endothelial (angiopoietin) markers dosages
Measured: at h0, h1, h4, h6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
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 Adult Patients Ventilated More Than 48 hStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098773
- Sponsor's protocol ID
- CHU-0069
- Other IDs
- 2009-A01310-57
- Acronym
- PULCO
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2010
- Last updated
- 7 Aug 2026
- Results posted
- No
Publications
Jabaudon M, Perbet S, Pereira B, Soummer A, Roszyk L, Guerin R, Futier E, Lu Q, Bazin JE, Sapin V, Rouby JJ, Constantin JM. Plasma levels of sRAGE, loss of aeration and weaning failure in ICU patients: a prospective observational multicenter study. PLoS One. 2013 May 27;8(5):e64083. doi: 10.1371/journal.pone.0064083. Print 2013.
PubMed 23724022
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary and Cardiac Ultrasound During Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01098773
- Acronym / sponsor ID
- PULCO / CHU-0069
- Conditions
- Adult Patients Ventilated More Than 48 h, Stable Respiratory and Hemodynamic Conditions for SBT, Consent of Patients, Arterial Line
- Keywords
- Weaning from mechanical ventilation, BNP, Lung ultrasound, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Apr 2010 (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.
Prospective observational clinical multicentric study in ICU with ventilated patients requiring chest ultrasound analysis.
Detailed description
Prospective observational clinical multicentric study on ICU ventilated patients requiring chest ultrasound analysis during weaning from mechanical ventilation with 48 hours of follow-up. Studying variations of cardiac markers
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients requiring ventilation | – | – |
| patients who weaned permanently | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective observational clinical multicentric study on ICU ventilated patients requiring chest ultrasound analysis during weaning from mechanical ventilation with 48 hours of follow-up. Studying variations of cardiac markers
Key inclusion criteria (4 listed)
- Adult patients ventilated more than 48 h
- Stable respiratory and hemodynamic conditions for SBT
- Consent of patients
- Arterial line
Key exclusion criteria (5 listed)
- Laryngeal dyspnea
- Tracheostomy
- Arythmya
- No echogenicity
- Paraplegia >T8
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
Compare the change in pulmonary aeration during the test of weaning from mechanical ventilation (before, at the end, and 4-6 h after) between patients requiring re-ventilation before the 48th hour, and those weaned permanently.
Time frame: before, at the end, and 4-6 h after
Compare the change in pulmonary aeration during the test of weaning from mechanical ventilation (before, at the end, and 4-6 h after) between patients requiring re-ventilation before the 48th hour, and those weaned permanently.
6 secondary outcomes
Studying variations, during weaning from mechanical ventilation, of pressure of left ventricle filling (E / Ea) coupled with those of plasma BNP.
Time frame: in the 4-6 early hours
Assessing the effects of E / Ea and BNP variations on the success or failure in the 4-6 early hours.
Time frame: in the 4-6 early hours.
Compare the variations of lung ultrasound score during the test of the weaning from mechanical ventilation between patients failed the spontaneous breathing test (SBT) and those extubated after successful SBT.
Time frame: in the 4-6 early hours
Comparison of levels epithelial and endothelial markers
Time frame: at h0, h1, h4, h6
Constitution serum bank for epithelial (sRAGE) markers dosages
Time frame: at h0, h1, h4, h6
constitution serum bank for endothelial (angiopoietin) markers dosages
Time frame: at h0, h1, h4, h6
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 7 Aug 2026.
- Results publication: PubMed 23724022Jabaudon M, Perbet S, Pereira B, Soummer A, Roszyk L, Guerin R, Futier E, Lu Q, Bazin JE, Sapin V, Rouby JJ, Constantin JM. Plasma levels of sRAGE, loss of aeration and weaning failure in ICU patients: a prospective observational multicenter study. PLoS One. 2013 May 27;8(5):e64083. doi: 10.1371/journal.pone.0064083. Print 2013.
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.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
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 Adult Patients Ventilated More Than 48 h and Stable Respiratory and Hemodynamic Conditions for SBT, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 5 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 7 Aug 2026. 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?
Compare the change in pulmonary aeration during the test of weaning from mechanical ventilation (before, at the end, and 4-6 h after) between patients requiring re-ventilation before the 48th hour, and those weaned permanently. (time frame: before, at the end, and 4-6 h after). 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 NCT01098773, 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 7 Aug 2026.