Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury

Acute Lung Injury Clinical Trial

Official title:

Measurement of Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury Using Electrical Impedance Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01107847
• Other study ID #: UKSH ROP/RCP
• Status: Recruiting
• Phase: N/A
• First received: April 19, 2010
• Last updated: April 20, 2010

Study information

• Verified date: March 2010
• Source: University of Schleswig-Holstein
• Contact: Sven Pulletz, M.D.
• Phone: +49 431 597 2991
• Email: pulletz[@]anaesthesie.uni-kiel.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult

Intervention

Procedure:
• low flow pressure volume manoeuvre
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.

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine, University Medical Center of Schleswig-Holstein, Campus Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. Epub 2003 Dec 23. — View Citation

Wrigge H, Zinserling J, Muders T, Varelmann D, Günther 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year	No
Secondary	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.	one year	No