Pulmonary and Cardiac Ultrasound During Weaning From Mechanical Ventilation

NCT01098773 | Completed

• 2 other identifiers: CHU-00692009-A01310-57
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

• 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.

• 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

• Comparison of levels epithelial and endothelial markers

  at h0, h1, h4, h6

• Constitution serum bank for epithelial (sRAGE) markers dosages

  at h0, h1, h4, h6

Study Arms (2)

patients requiring ventilation

patients who weaned permanently

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- Adult patients ventilated more than 48 h
• Stable respiratory and hemodynamic conditions for SBT
• Consent of patients
• Arterial line

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Groupe Hospitalier Pitie-Salpetriere: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• 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.

  PMID: 23724022 DERIVED

Study Officials

• Sébastien PERBET

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 5, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

FR (1)