FRC Guided Therapy in Acute Respiratory Failure

Cardiac Surgery Clinical Trial

Official title:

Functional Residual Capacity Guided Alveolar Recruitment Strategy in Patients With Acute Respiratory Failure After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01280019
• Other study ID #: FRC-ARF
• Status: Recruiting
• Phase: Phase 4
• First received: January 19, 2011
• Last updated: January 19, 2011
• Start date: October 2010
• Est. completion date: May 2012

Study information

• Verified date: January 2011
• Source: University of Luebeck
• Contact: Hermann Heinze, MD
• Email: Hermann.heinze[@]uk-sh.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

In ventilated patients with acute respiratory failure endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. Regional distribution of ventilation can be followed at bedside using electrical impedance tomography. The investigators hypothesize that a FRC guided recruitment strategy, aimed at restoring a baseline FRC value after open endotracheal suctioning, improves oxygenation and regional distribution of ventilation. In addition the investigators research the impact of such a strategy on the inflammatory response to mechanical ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• need for mechanical ventilation due to respiratory failure after cardiac surgery

Exclusion Criteria:

• circulatory failure, eg. need for high doses of inotropes or extracorporal cardiac support

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Cardiac Surgery
• Mechanical Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Procedure:
• alveolar recruitment manoeuvre
Increase of airway pressures in a stepwise manner from set peak inspiratory pressure/ positive end-expiratory pressure up to 40/15 mbar and back over 2 minutes.

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology, Intensive Care Unit, University of Lübeck	Lübeck

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	European Society of Intensive Care Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional ventilation	Regional distribution of ventilation over 6 hours of treatment	6 hours	No
Secondary	arterial oxygenation and inflammation	Changes of arterial oxygenation and inflammatory parameters in the blood during 6 hours of treatment	6 hours	No