Clinical trial NCT01107847: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Lung Injury
Keywords: electrical impedance tomography
EIT
acute lung injury
regional lung opening pressure
regional lung closing pressure
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2010-04-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Measurement of regional lung opening pressures
timeFrame: one year
Secondary outcomes:
measure: Measurement of regional closing pressures
timeFrame: one year
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, University Medical Center of Schleswig-Holstein, Campus Kiel
Study officials:
affiliation: University Medical Center of Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine
name: Jens Scholz, M.D.
role: STUDY_CHAIR
References:
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.
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.
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.