Pediatric ARDSNCT02036801
The Specific Elastance in ARDS Patients: a Pediatric Study
An observational study of Pediatric ARDS, run by Policlinico Hospital at 1 site in Italy.
Trial summary
Aim of this study is to assess lung specific elastance in a population of pediatric patients with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in a pediatric population of ICU patients with healthy lung which are treated with mechanical ventilation for other clinical purposes. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Pediatric ARDS
- What is being tested?
- Lung specific elastance
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to Dec 2014
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: ARDS pediatric patients in mechanical ventilation or patients with healthy lung treated with mechanical ventilation for clinical purposes
Who may be able to join
- ARDS (Berlin Definition Criteria) or mechanical ventilation in healthy lungs
Who cannot join
- Hemodynamic instability
- Lung diseases other than ARDS
- Parental refuse
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCC Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: The Specific Elastance in ARDS Patients. Connections Between Volutrauma and Barotrauma - A Pediatric Study
Aim of this study is to assess lung specific elastance in a population of pediatric patients with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in a pediatric population of ICU patients with healthy lung which are treated with mechanical ventilation for other clinical purposes.
- Conditions
- Pediatric ARDS
- Being tested
- Lung specific elastance
- Keywords
- ARDS, Lung, Specific Elastance, Pediatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung specific elastanceOther
Measurement of lung specific elastance and lung mechanical characteristics at different PEEP levels and tidal volumes
| Study group | Role | What they receive |
|---|---|---|
| ARDS | Patients with ARDS (according to the Berlin Definition criteria) in mechanical ventilation Receives: Other: Lung specific elastance | |
| Healthy control | Patients with healthy lung supported with mechanical ventilation for clinical purposes Receives: Other: Lung specific elastance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific elastance of the lung
Measured: 10 minutes from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJun 2009
- Primary completionDec 2014
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 Pediatric ARDSStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036801
- Sponsor's protocol ID
- policlinico-10
- Status last verified
- Mar 2015
- First submitted
- 13 Jan 2014
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chiumello D, Chidini G, Calderini E, Colombo A, Crimella F, Brioni M. Respiratory mechanics and lung stress/strain in children with acute respiratory distress syndrome. Ann Intensive Care. 2016 Dec;6(1):11. doi: 10.1186/s13613-016-0113-0. Epub 2016 Feb 5.
PubMed 26847436
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Specific Elastance in ARDS Patients. Connections Between Volutrauma and Barotrauma - A Pediatric Study
- ClinicalTrials.gov ID
- NCT02036801
- Acronym / sponsor ID
- policlinico-10
- Conditions
- Pediatric ARDS
- Keywords
- ARDS, Lung, Specific Elastance, Pediatric patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2014 (actual)
- First posted
- 15 Jan 2014 (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.
Aim of this study is to assess lung specific elastance in a population of pediatric patients with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in a pediatric population of ICU patients with healthy lung which are treated with mechanical ventilation for other clinical purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS | – | Other: Lung specific elastancePatients with ARDS (according to the Berlin Definition criteria) in mechanical ventilation |
| Healthy control | – | Other: Lung specific elastancePatients with healthy lung supported with mechanical ventilation for clinical purposes |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- ARDS pediatric patients in mechanical ventilation or patients with healthy lung treated with mechanical ventilation for clinical purposes
Key inclusion criteria (1 listed)
- ARDS (Berlin Definition Criteria) or mechanical ventilation in healthy lungs
Key exclusion criteria (3 listed)
- Hemodynamic instability
- Lung diseases other than ARDS
- Parental refuse
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 |
|---|---|---|
| Lung specific elastanceMeasurement of lung specific elastance and lung mechanical characteristics at different PEEP levels and tidal volumes | Other | ARDS, Healthy control |
Primary outcome
Specific elastance of the lung
Time frame: 10 minutes from the start of the study
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 19 Mar 2015.
- Derived from this study: PubMed 26847436Chiumello D, Chidini G, Calderini E, Colombo A, Crimella F, Brioni M. Respiratory mechanics and lung stress/strain in children with acute respiratory distress syndrome. Ann Intensive Care. 2016 Dec;6(1):11. doi: 10.1186/s13613-016-0113-0. Epub 2016 Feb 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pediatric ARDS, run by Policlinico Hospital at 1 site in Italy.
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 3 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 19 Mar 2015. 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 Italy. 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.
What does the primary outcome measure?
Specific elastance of the lung (time frame: 10 minutes from the start of the study). 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 NCT02036801, 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 19 Mar 2015.