Critically IllNCT00258518
Respiratory Mechanics and Pleural Effusion
An observational study of Critically Ill and Acute Lung Injury, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The investigators aim to compare the respiratory mechanics in acute lung injury (ALI)/acute respiratory diseases syndrome (ARDS) patients with and without pleural effusion. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Critically Ill, Acute Lung Injury, ARDS
- What is being tested?
- mechanical ventilation/CT Scan
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2005to Jun 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 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ALI/ARDS patients
Who may be able to join
- ALI/ARDS patients underwent invasive mechanical ventilation
Who cannot join
- Haemodynamic instability
- Chronic obstructive pulmonary disease (COPD) patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Respiratory Mechanics (Respiratory System, Chest Wall and Lung Elastance) and Pleural Effusion at the Bedside With CT Scan.
The investigators aim to compare the respiratory mechanics in acute lung injury (ALI)/acute respiratory diseases syndrome (ARDS) patients with and without pleural effusion.
Read the detailed description
In ALI/ARDS we evaluated the respiratory mechanics (respiratory system, chest wall and lung elastance) at the bedside while pleural effusion was evaluated with CT scan. Thus we will be able to estimate any possible role of pleural effusion on the respiratory mechanics.
- Conditions
- Critically Ill, Acute Lung Injury, ARDS
- Being tested
- mechanical ventilation/CT Scan
- Keywords
- Critically ill patients
- Medical subject headings
- Critical Illness, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilation/CT ScanProcedure or surgery
evaluation of pleural effusion and respiratory mechanics, CT scan
| Study group | Role | What they receive |
|---|---|---|
| 1 | ALI/ARDS patients Receives: Procedure: mechanical ventilation/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of pleural effusion and respiratory mechanics
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, Policlinico Hospital
- Investigators
- Davide Chiumello, MD, Principal investigator, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258518
- Sponsor's protocol ID
- 1500
- Status last verified
- Mar 2012
- First submitted
- 23 Nov 2005
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Respiratory Mechanics (Respiratory System, Chest Wall and Lung Elastance) and Pleural Effusion at the Bedside With CT Scan.
- ClinicalTrials.gov ID
- NCT00258518
- Acronym / sponsor ID
- 1500
- Conditions
- Critically Ill, Acute Lung Injury, ARDS
- Keywords
- Critically ill patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Nov 2005 (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 compare the respiratory mechanics in acute lung injury (ALI)/acute respiratory diseases syndrome (ARDS) patients with and without pleural effusion.
Detailed description
In ALI/ARDS we evaluated the respiratory mechanics (respiratory system, chest wall and lung elastance) at the bedside while pleural effusion was evaluated with CT scan. Thus we will be able to estimate any possible role of pleural effusion on the respiratory mechanics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: mechanical ventilation/CT ScanALI/ARDS patients |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ALI/ARDS patients
Key inclusion criteria (1 listed)
- ALI/ARDS patients underwent invasive mechanical ventilation
Key exclusion criteria (2 listed)
- Haemodynamic instability
- Chronic obstructive pulmonary disease (COPD) patients
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 ventilation/CT Scanevaluation of pleural effusion and respiratory mechanics, CT scan | Procedure or surgery | 1 |
Primary outcome
Role of pleural effusion and respiratory mechanics
Time frame: 1 hour
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 8 Mar 2012.
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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?
An observational study of Critically Ill and Acute Lung Injury, 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 8 Mar 2012. 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?
Role of pleural effusion and respiratory mechanics (time frame: 1 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 8 Mar 2012.