Pulmonary and Cardiac Ultrasound During Weaning From Mechanical Ventilation

Arterial Line Clinical Trial

— PULCO  

Official title:

Pulmonary and Cardiac Ultrasound During Weaning From Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098773
• Other study ID #: CHU-0069
• Secondary ID: 2009-A01310-57
• Status: Completed
• Phase: N/A
• First received: April 1, 2010
• Last updated: July 4, 2014
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Prospective observational clinical multicentric study in ICU with ventilated patients requiring chest ultrasound analysis.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adult Patients Ventilated More Than 48 h
• Arterial Line
• Consent of Patients
• Stable Respiratory and Hemodynamic Conditions for SBT

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before, at the end, and 4-6 h after	Yes
Secondary	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.	in the 4-6 early hours	Yes
Secondary	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.	in the 4-6 early hours.	Yes
Secondary	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.	in the 4-6 early hours	Yes
Secondary	Comparison of levels epithelial and endothelial markers		at h0, h1, h4, h6	Yes
Secondary	Constitution serum bank for epithelial (sRAGE) markers dosages		at h0, h1, h4, h6	Yes
Secondary	constitution serum bank for endothelial (angiopoietin) markers dosages		at h0, h1, h4, h6	Yes