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FRC Guided Therapy in Acute Respiratory Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by University of Luebeck.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280019
First Posted: January 20, 2011
Last Update Posted: January 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
European Society of Intensive Care Medicine
Information provided by:
University of Luebeck
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Regional ventilation [ Time Frame: 6 hours ]
    Regional distribution of ventilation over 6 hours of treatment


Secondary Outcome Measures:
  • arterial oxygenation and inflammation [ Time Frame: 6 hours ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Hermann Heinze, Department of Anaesthesiology, University of Lübeck
ClinicalTrials.gov Identifier: NCT01280019     History of Changes
Other Study ID Numbers: FRC-ARF
First Submitted: January 19, 2011
First Posted: January 20, 2011
Last Update Posted: January 20, 2011
Last Verified: January 2011

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

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