Clinical trial NCT01098773: Pulmonary and Cardiac Ultrasound During Weaning From Mechanical Ventilation
Official title: Pulmonary and Cardiac Ultrasound During Weaning From Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Groupe Hospitalier Pitie-Salpetriere
First posted: 2010-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

- Adult patients ventilated more than 48 h

* Stable respiratory and hemodynamic conditions for SBT
* Consent of patients
* Arterial line

Exclusion Criteria:

* Laryngeal dyspnea
* Tracheostomy
* Arythmya
* No echogenicity
* Paraplegia \>T8

Primary outcomes:
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.
timeFrame: before, at the end, and 4-6 h after
Secondary outcomes:
measure: Studying variations, during weaning from mechanical ventilation, of pressure of left ventricle filling (E / Ea) coupled with those of plasma BNP.
timeFrame: in the 4-6 early hours
measure: Assessing the effects of E / Ea and BNP variations on the success or failure in the 4-6 early hours.
timeFrame: in the 4-6 early hours.
measure: 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.
timeFrame: in the 4-6 early hours
measure: Comparison of levels epithelial and endothelial markers
timeFrame: at h0, h1, h4, h6
measure: Constitution serum bank for epithelial (sRAGE) markers dosages
timeFrame: at h0, h1, h4, h6
measure: constitution serum bank for endothelial (angiopoietin) markers dosages
timeFrame: at h0, h1, h4, h6
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.