Back to resultsFRC Guided Therapy in Acute Respiratory Failure
Primary Purpose
Mechanical Ventilation, Acute Respiratory Failure, Cardiac Surgery
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
alveolar recruitment manoeuvre
Sponsored by
About this trial
This is an interventional supportive care trial for Mechanical Ventilation focused on measuring functional residual capacity, electrical impedance tomography, inflammatory parameters
Eligibility 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
Sites / Locations
- Department of Anaesthesiology, Intensive Care Unit, University of LübeckRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FRC guided
Saturation guided
Arm Description
Patients receive an alveolar recruitment manoeuvre if FRC falls below 94% of baseline FRC
Patients receive an alveolar recruitment manoeuvre if peripheral oxygen saturation falls below 90%
Outcomes
Primary Outcome Measures
Regional ventilation
Regional distribution of ventilation over 6 hours of treatment
Secondary Outcome Measures
arterial oxygenation and inflammation
Changes of arterial oxygenation and inflammatory parameters in the blood during 6 hours of treatment
Full Information
NCT ID
NCT01280019
First Posted
January 19, 2011
Last Updated
January 19, 2011
Sponsor
University of Luebeck
Collaborators
European Society of Intensive Care Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01280019
Brief Title
FRC Guided Therapy in Acute Respiratory Failure
Official Title
Functional Residual Capacity Guided Alveolar Recruitment Strategy in Patients With Acute Respiratory Failure After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
May 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Luebeck
Collaborators
European Society of Intensive Care Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Acute Respiratory Failure, Cardiac Surgery
Keywords
functional residual capacity, electrical impedance tomography, inflammatory parameters
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FRC guided
Arm Type
Experimental
Arm Description
Patients receive an alveolar recruitment manoeuvre if FRC falls below 94% of baseline FRC
Arm Title
Saturation guided
Arm Type
Active Comparator
Arm Description
Patients receive an alveolar recruitment manoeuvre if peripheral oxygen saturation falls below 90%
Intervention Type
Procedure
Intervention Name(s)
alveolar recruitment manoeuvre
Intervention Description
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.
Primary Outcome Measure Information:
Title
Regional ventilation
Description
Regional distribution of ventilation over 6 hours of treatment
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
arterial oxygenation and inflammation
Description
Changes of arterial oxygenation and inflammatory parameters in the blood during 6 hours of treatment
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hermann Heinze, MD
Email
Hermann.heinze@uk-sh.de
Facility Information:
Facility Name
Department of Anaesthesiology, Intensive Care Unit, University of Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermann Heinze, MD
Phone
+49 451 500
Ext
4057
Email
Hermann.heinze@uk-sh.de
First Name & Middle Initial & Last Name & Degree
Hermann Heinze, MD
12. IPD Sharing Statement
Learn more about this trial
FRC Guided Therapy in Acute Respiratory Failure
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