Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury
Primary Purpose
Acute Lung Injury
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
low flow pressure volume manoeuvre
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Lung Injury focused on measuring electrical impedance tomography, EIT, acute lung injury, regional lung opening pressure, regional lung closing pressure
Eligibility Criteria
Inclusion Criteria:
- artificial ventilation
- acute lung injury / healthy lung (control group)
Exclusion Criteria:
- pregnancy
- Cerebral trauma / surgery
- Age < 18 years
- instable cardiovascular disease
- instable chest wall
Sites / Locations
- Department of Anesthesiology and Intensive Care Medicine, University Medical Center of Schleswig-Holstein, Campus KielRecruiting
Outcomes
Primary Outcome Measures
Measurement of regional lung opening pressures
For the measurement of regional opening pressures in lung healthy and acute lung injury an inspiratory low flow manoeuvre with synchronous measurement of regional ventilation and airway pressure is performed. The regional opening pressures are defined as the airway pressure to the point were the regional lung areas open up.
Secondary Outcome Measures
Measurement of regional closing pressures
For the measurement of regional closing pressures in lung healthy and acute lung injury an expiratory low flow manoeuvre with synchronous measurement of regional ventilation and airway pressure is performed. The regional closing pressures are defined as the airway pressure to the point were the regional lung areas start closing.
Full Information
NCT ID
NCT01107847
First Posted
April 19, 2010
Last Updated
April 20, 2010
Sponsor
University Hospital Schleswig-Holstein
1. Study Identification
Unique Protocol Identification Number
NCT01107847
Brief Title
Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury
Official Title
Measurement of Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury Using Electrical Impedance Tomography
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Schleswig-Holstein
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is the measurement of regional opening and closing pressures of lung tissue by electrical impedance tomography in lung healthy and patients with acute lung injury. These values might help the setting of positive endexpiratory pressure during artificial ventilation to avoid the cyclic opening and closing of alveoli.
Detailed Description
During artificial ventilation the cyclic opening and closing of alveoli during artificial ventilation results in patients with acute lung injury (ALI) in a higher mortality. A positive endexpiratory pressure (PEEP) is applied with the intention to avoid these cyclic opening and closing of alveoli. The distribution of ventilation in patients with ALI is extremely inhomogeneous, consequently there are different regional opening pressures needed to open up the alveoli and avoid closing. Finding the best level of PEEP in patients with injured lungs to avoid atelectasis and alveolar strain induced by inadequately high or low PEEP levels is a challenge.
The purpose of this study is to develop a protocol for measuring regional opening and closing pressures using the method of electrical impedance tomography in lung healthy and ALI patients. A ventilator setting guided by regional opening and closing pressures might help reducing the impairment of the lung by artificial ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
electrical impedance tomography, EIT, acute lung injury, regional lung opening pressure, regional lung closing pressure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
low flow pressure volume manoeuvre
Intervention Description
In all patients a standard low flow pressure volume manoeuvre is applied by a respirator with a constant gas flow of 4 l/min starting at a zero end-expiratory pressure up to a tidal volume of 2 l or until a maximum airway pressure of 35 cm H2O was reached.
Primary Outcome Measure Information:
Title
Measurement of regional lung opening pressures
Description
For the measurement of regional opening pressures in lung healthy and acute lung injury an inspiratory low flow manoeuvre with synchronous measurement of regional ventilation and airway pressure is performed. The regional opening pressures are defined as the airway pressure to the point were the regional lung areas open up.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Measurement of regional closing pressures
Description
For the measurement of regional closing pressures in lung healthy and acute lung injury an expiratory low flow manoeuvre with synchronous measurement of regional ventilation and airway pressure is performed. The regional closing pressures are defined as the airway pressure to the point were the regional lung areas start closing.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
artificial ventilation
acute lung injury / healthy lung (control group)
Exclusion Criteria:
pregnancy
Cerebral trauma / surgery
Age < 18 years
instable cardiovascular disease
instable chest wall
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sven Pulletz, M.D.
Phone
+49 431 597 2991
Email
pulletz@anaesthesie.uni-kiel.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Scholz, M.D.
Organizational Affiliation
University Medical Center of Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care Medicine, University Medical Center of Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Pulletz, M.D.
Phone
+ 49 431 597 2991
Email
pulletz@anaesthesie.uni-kiel.de
First Name & Middle Initial & Last Name & Degree
Inéz Frerichs, M.D.
Phone
+ 49 431 597 2991
Email
frerichs@anaesthesie.uni-kiel.de
First Name & Middle Initial & Last Name & Degree
Sven Pulletz, M.D.
First Name & Middle Initial & Last Name & Degree
Matthias Kott, M.D.
First Name & Middle Initial & Last Name & Degree
Gunnar Elke, M.D.
First Name & Middle Initial & Last Name & Degree
Dirk Schaedler, M.D.
First Name & Middle Initial & Last Name & Degree
Guenther Zick, M.D.
First Name & Middle Initial & Last Name & Degree
Barbara Gawelczyk, M.D.
First Name & Middle Initial & Last Name & Degree
Norbert Weiler, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
19910610
Citation
Caironi P, Cressoni M, Chiumello D, Ranieri M, Quintel M, Russo SG, Cornejo R, Bugedo G, Carlesso E, Russo R, Caspani L, Gattinoni L. Lung opening and closing during ventilation of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2010 Mar 15;181(6):578-86. doi: 10.1164/rccm.200905-0787OC. Epub 2009 Nov 12.
Results Reference
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PubMed Identifier
18431279
Citation
Wrigge H, Zinserling J, Muders T, Varelmann D, Gunther U, von der Groeben C, Magnusson A, Hedenstierna G, Putensen C. Electrical impedance tomography compared with thoracic computed tomography during a slow inflation maneuver in experimental models of lung injury. Crit Care Med. 2008 Mar;36(3):903-9. doi: 10.1097/CCM.0B013E3181652EDD.
Results Reference
background
PubMed Identifier
14693669
Citation
Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.
Results Reference
background
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Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury
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