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FRC Guided Therapy in Acute Respiratory Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Luebeck.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
European Society of Intensive Care Medicine
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT01280019
First received: January 19, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Mechanical Ventilation
Acute Respiratory Failure
Cardiac Surgery
 Procedure: alveolar recruitment manoeuvre
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Functional Residual Capacity Guided Alveolar Recruitment Strategy in Patients With Acute Respiratory Failure After Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Regional ventilation [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Regional distribution of ventilation over 6 hours of treatment


Secondary Outcome Measures:
  • arterial oxygenation and inflammation [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Changes of arterial oxygenation and inflammatory parameters in the blood during 6 hours of treatment


Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FRC guided
Patients receive an alveolar recruitment manoeuvre if FRC falls below 94% of baseline FRC
 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.
Active Comparator: Saturation guided
Patients receive an alveolar recruitment manoeuvre if peripheral oxygen saturation falls below 90%
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280019

Contacts
Contact: Hermann Heinze, MD Hermann.heinze@uk-sh.de

Locations
Germany
Department of Anaesthesiology, Intensive Care Unit, University of Lübeck Recruiting
Lübeck, Germany, 23538
Contact: Hermann Heinze, MD     +49 451 500 ext 4057     Hermann.heinze@uk-sh.de    
Principal Investigator: Hermann Heinze, MD            
Sponsors and Collaborators
University of Luebeck
European Society of Intensive Care Medicine
  More Information

No publications provided

Responsible Party: Dr. Hermann Heinze, Department of Anaesthesiology, University of Lübeck
ClinicalTrials.gov Identifier: NCT01280019     History of Changes
Other Study ID Numbers: FRC-ARF
Study First Received: January 19, 2011
Last Updated: January 19, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Luebeck:
functional residual capacity
electrical impedance tomography
inflammatory parameters

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 23, 2013