NCT01107847

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
Last Updated

April 21, 2010

Status Verified

March 1, 2010

First QC Date

April 19, 2010

Last Update Submit

April 20, 2010

Conditions

Keywords

electrical impedance tomographyEITacute lung injuryregional lung opening pressureregional lung closing pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Measurement of regional closing pressures

    one year

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • artificial ventilation
  • acute lung injury / healthy lung (control group)

You may not qualify if:

  • pregnancy
  • Cerebral trauma / surgery
  • Age \< 18 years
  • instable cardiovascular disease
  • instable chest wall

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, University Medical Center of Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

RECRUITING

Related 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.

    PMID: 19910610BACKGROUND
  • 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.

    PMID: 18431279BACKGROUND
  • 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.

    PMID: 14693669BACKGROUND

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jens Scholz, M.D.

    University Medical Center of Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 21, 2010

Last Updated

April 21, 2010

Record last verified: 2010-03

Locations