Acute Lung InjuryNCT02948530
Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods (Lungbarometry)
An observational study of Acute Lung Injury, run by Stefan Lundin at 1 site in Sweden.
Trial summary
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2016to Dec 2018
- Phase
- Observational
- 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
Study population: Sedated and mechanically ventilated patients in the intensive care unit
Who may be able to join
- Mechanically ventilated patients in the intensive care unit
Who cannot join
- Patients with chronic obstrucive lung disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, S-413 45
Stefan Lundin, MD PhD, +46 708744379, stefan.lundin@gu.se
Magni Gudmundsson, MD
About this study
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. The measurements are performed in sedated and mechanically ventilated patients in the intensive care unit.
Read the detailed description
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly.
In this study values obtained as described in Method 1 above are compared to values obtained with a new method (Method 2) in which a PEEP-step is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in sedated and mechanically ventilated patients in the intensive care unit.
- Conditions
- Acute Lung Injury
- Medical subject headings
- Acute Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of lung elastance and transpulmonary pressure
Comparison of a new versus the classical method for measurement of transpulmonary pressure
Measured: Within one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefan Lundin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Lundin, Sahlgrenska University Hospital
- Investigators
- Stefan Lundin, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948530
- Sponsor's protocol ID
- LUA-74204
- Status last verified
- Apr 2018
- First submitted
- 26 Oct 2016
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods (Lungbarometry)
- ClinicalTrials.gov ID
- NCT02948530
- Acronym / sponsor ID
- LUA-74204
- Conditions
- Acute Lung Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stefan LundinUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Oct 2016 (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.
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. The measurements are performed in sedated and mechanically ventilated patients in the intensive care unit.
Detailed description
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly.
In this study values obtained as described in Method 1 above are compared to values obtained with a new method (Method 2) in which a PEEP-step is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in sedated and mechanically ventilated patients in the intensive care unit.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sedated and mechanically ventilated patients in the intensive care unit
Key inclusion criteria (1 listed)
- Mechanically ventilated patients in the intensive care unit
Key exclusion criteria (1 listed)
- Patients with chronic obstrucive lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of lung elastance and transpulmonary pressure
Time frame: Within one hour
Comparison of a new versus the classical method for measurement of transpulmonary pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Stefan Lundin, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury, run by Stefan Lundin at 1 site in Sweden.
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 1 inclusion and 1 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 11 Apr 2018. 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 Sweden. 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 Stefan Lundin, MD, PhD (+46313428112, stefan.lundin@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of lung elastance and transpulmonary pressure (time frame: Within one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2018.