Acute Lung InjuryNCT01107847
Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury
A study testing low flow pressure volume manoeuvre in people with Acute Lung Injury, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- low flow pressure volume manoeuvre
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- artificial ventilation
- acute lung injury / healthy lung (control group)
Who cannot join
- pregnancy
- Cerebral trauma / surgery
- Age < 18 years
- instable cardiovascular disease
- instable chest wall
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Intensive Care Medicine, University Medical Center of Schleswig-Holstein, Campus Kiel
Kiel, 24105
Sven Pulletz, M.D., + 49 431 597 2991, pulletz@anaesthesie.uni-kiel.de
Inéz Frerichs, M.D., + 49 431 597 2991, frerichs@anaesthesie.uni-kiel.de
About this study
Official title: Measurement of Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury Using Electrical Impedance Tomography
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.
Read the 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.
- Conditions
- Acute Lung Injury
- Being tested
- low flow pressure volume manoeuvre
- Keywords
- electrical impedance tomography, EIT, acute lung injury, regional lung opening pressure, regional lung closing pressure
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low flow pressure volume manoeuvreProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Investigators
- Jens Scholz, M.D., Study chair, University Medical Center of Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107847
- Sponsor's protocol ID
- UKSH ROP/RCP
- Status last verified
- Mar 2010
- First submitted
- 19 Apr 2010
- Last updated
- 21 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19910610Wrigge 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.
PubMed 18431279Victorino 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.
PubMed 14693669
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Regional Lung Opening and Closing Pressures in Patients With Acute Lung Injury Using Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT01107847
- Acronym / sponsor ID
- UKSH ROP/RCP
- Conditions
- Acute Lung Injury
- Keywords
- electrical impedance tomography, EIT, acute lung injury, regional lung opening pressure, regional lung closing pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- artificial ventilation
- acute lung injury / healthy lung (control group)
Key exclusion criteria (5 listed)
- pregnancy
- Cerebral trauma / surgery
- Age < 18 years
- instable cardiovascular disease
- instable chest wall
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low flow pressure volume manoeuvreIn 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. | Procedure or surgery | – |
Primary outcome
Measurement of regional lung opening pressures
Time frame: one year
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.
1 secondary outcome
Measurement of regional closing pressures
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2010.
- Background: PubMed 19910610Caironi 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.
- Background: PubMed 18431279Wrigge 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.
- Background: PubMed 14693669Victorino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Scholz, M.D. study chair
University Medical Center of Schleswig-Holstein, Campus Kiel, Department of Anesthesiology and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low flow pressure volume manoeuvre in people with Acute Lung Injury, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sven Pulletz, M.D. (+49 431 597 2991, pulletz@anaesthesie.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of regional lung opening pressures (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01107847, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2010.