Acute Respiratory Distress SyndromeNCT00284102
PEEP Test and Gas Exchange in ALI/ARDS Patients
A study testing Mechanical ventilation in people with Acute Respiratory Distress Syndrome, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on gas exchange. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Apr 2008
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ALI/ARDS patients requiring mechanical ventilation
Who cannot join
- Hemodynamic instability
- Barotrauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive End Expiratory Pressure (PEEP) Test and Gas Exchange in ALI/ARDS Patients
The investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on gas exchange.
Read the detailed description
In a population of ALI/ARDS patients during mechanical ventilation we will evaluate the effect of different levels of PEEP on gas exchange and dead space.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Mechanical ventilation
- Keywords
- gas exchange, dead space, respiratory failure, ALI/ARDS patients
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationProcedure or surgery
measurement of gas exchange, dead space, respiratory mechanics 5, 15, 30, 60 minutes from PEEP change (5 and 15 cmH2O)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ALI/ARDS patients Receives: Procedure: Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gas exchange, dead space, respiratory mechanics
Measured: 5, 15, 30, 60 minutes from PEEP change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Davide Chiumello, MD, Principal investigator, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284102
- Sponsor's protocol ID
- 1700
- Status last verified
- Sep 2008
- First submitted
- 30 Jan 2006
- Last updated
- 25 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive End Expiratory Pressure (PEEP) Test and Gas Exchange in ALI/ARDS Patients
- ClinicalTrials.gov ID
- NCT00284102
- Acronym / sponsor ID
- 1700
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- gas exchange, dead space, respiratory failure, ALI/ARDS patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Jan 2006 (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 investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on gas exchange.
Detailed description
In a population of ALI/ARDS patients during mechanical ventilation we will evaluate the effect of different levels of PEEP on gas exchange and dead space.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Mechanical ventilationALI/ARDS patients |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ALI/ARDS patients requiring mechanical ventilation
Key exclusion criteria (2 listed)
- Hemodynamic instability
- Barotrauma
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 |
|---|---|---|
| Mechanical ventilationmeasurement of gas exchange, dead space, respiratory mechanics 5, 15, 30, 60 minutes from PEEP change (5 and 15 cmH2O) | Procedure or surgery | 1 |
Primary outcome
Gas exchange, dead space, respiratory mechanics
Time frame: 5, 15, 30, 60 minutes from PEEP change
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 25 Sep 2008.
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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.
Davide Chiumello, MD principal investigator
Policlinico Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation in people with Acute Respiratory Distress Syndrome, 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 2 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 25 Sep 2008. 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?
Gas exchange, dead space, respiratory mechanics (time frame: 5, 15, 30, 60 minutes from PEEP change). 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 25 Sep 2008.