Acute Respiratory Distress SyndromeNCT01478217
PEEP Recruitment-comparison Between Ultrasonographic Assessment and LIP Assessment
An observational study of Acute Respiratory Distress Syndrome, run by Sisters of Mercy University Hospital at 1 site in Croatia.
Trial summary
The purpose of this study is to compare lung recruitment in acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) based on lower inflection point with transthoracic ultrasonographic assessment of lung recruitment. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 17 participants
- Where
- 1 siteCroatia
- Study dates
- Oct 2009to Nov 2011
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: intensive care patients
Who may be able to join
- patients with diffuse ALI/ARDS on mechanical ventilation with visible lower inflection point on dynamic P-V loops
Who cannot join
- preexisting parenchymal or pleural lung disease
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Central intensive care unit, University hospital "Sisters of Mercy"
Grad Zagreb, 10000
About this study
Official title: Positive End-expiratory Pressure Induced Lung Recruitment -Comparison Between Ultrasonographic Assessment and Lower Inflection Point Assessment on the Pressure -Volume Loop
The purpose of this study is to compare lung recruitment in acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) based on lower inflection point with transthoracic ultrasonographic assessment of lung recruitment.
Read the detailed description
Sedated and sometimes temporary relaxed patients with ALI/ARDS on mechanical ventilation in semirecumbent position are included. Lower inflection point on pressure volume loop on ventilator Draeger Evita 4 with low continuous flow on volume controlled ventilation is measured with zero PEEP. Transthoracic lung ultrasound with linear probe is proceed on both hemithoraces when mechanical ventilation based on measured PEEP is started. We compare if real lung recruitment seen by ultrasound is the same as predicted by lower inflection point.
The procedure is a part of routine everyday respiratory monitoring in our unit.
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- lung ultrasonography, pressure-volume loops, ARDS
- Medical subject headings
- Respiratory Distress Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startOct 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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-control
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisters of Mercy University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bojan Rode, Sisters of Mercy University Hospital
- Investigators
- Bojan Rode, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478217
- Sponsor's protocol ID
- Vinogradska29
- Status last verified
- Nov 2011
- First submitted
- 20 Nov 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
PubMed 20851923
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive End-expiratory Pressure Induced Lung Recruitment -Comparison Between Ultrasonographic Assessment and Lower Inflection Point Assessment on the Pressure -Volume Loop
- ClinicalTrials.gov ID
- NCT01478217
- Acronym / sponsor ID
- Vinogradska29
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- lung ultrasonography, pressure-volume loops, ARDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sisters of Mercy University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Nov 2011 (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 to compare lung recruitment in acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) based on lower inflection point with transthoracic ultrasonographic assessment of lung recruitment.
Detailed description
Sedated and sometimes temporary relaxed patients with ALI/ARDS on mechanical ventilation in semirecumbent position are included. Lower inflection point on pressure volume loop on ventilator Draeger Evita 4 with low continuous flow on volume controlled ventilation is measured with zero PEEP. Transthoracic lung ultrasound with linear probe is proceed on both hemithoraces when mechanical ventilation based on measured PEEP is started. We compare if real lung recruitment seen by ultrasound is the same as predicted by lower inflection point.
The procedure is a part of routine everyday respiratory monitoring in our unit.
Study design
- Observational model
- Case-control
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- intensive care patients
Key inclusion criteria (1 listed)
- patients with diffuse ALI/ARDS on mechanical ventilation with visible lower inflection point on dynamic P-V loops
Key exclusion criteria (1 listed)
- preexisting parenchymal or pleural 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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
- Results publication: PubMed 20851923Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
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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.
Bojan Rode, M.D. principal investigator
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 Respiratory Distress Syndrome, run by Sisters of Mercy University Hospital at 1 site in Croatia.
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: finished, as of the sponsor's last update on 23 Nov 2011. 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 Croatia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01478217, which also lists 1 linked publication.
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 23 Nov 2011.