Respiratory Distress Syndrome, AdultNCT00267241
Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients
A study testing Mechanical Ventilation in people with Respiratory Distress Syndrome, Adult, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the effects in terms of gas exchange, respiratory mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Mechanical Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2005to Nov 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ALI/ARDS
Who cannot join
- COPD patients
- Barotrauma
- Hemodynamic instability
- Age less than 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients
The aim of this study is to evaluate the effects in terms of gas exchange, respiratory mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS patients.
Read the detailed description
ALI/ARDS patients (during assisted ventilation) will be ventilated with different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation) and gas exchange, comfort of breathing, respiratory mechanics and pattern of breathing will be measured.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Mechanical Ventilation
- Keywords
- ARDS, ALI, respiratory mechanics, gas exchange, assisted ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical VentilationOther
Four different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ALI/ARDS patients Receives: Other: Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gas exchange and respiratory mechanics
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT00267241
- Sponsor's protocol ID
- 1600
- Status last verified
- Apr 2015
- First submitted
- 19 Dec 2005
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Assisted Mechanical Ventilation in ALI/ARDS Patients
- ClinicalTrials.gov ID
- NCT00267241
- Acronym / sponsor ID
- 1600
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- ARDS, ALI, respiratory mechanics, gas exchange, assisted ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Dec 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 aim of this study is to evaluate the effects in terms of gas exchange, respiratory mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS patients.
Detailed description
ALI/ARDS patients (during assisted ventilation) will be ventilated with different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation) and gas exchange, comfort of breathing, respiratory mechanics and pattern of breathing will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Mechanical VentilationALI/ARDS patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ALI/ARDS
Key exclusion criteria (4 listed)
- COPD patients
- Barotrauma
- Hemodynamic instability
- Age less than 18
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 VentilationFour different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation) | Other | 1 |
Primary outcome
Gas exchange and respiratory mechanics
Time frame: 5 minutes
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 28 Apr 2015.
Related trials for Respiratory Distress Syndrome, Adult
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
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 Respiratory Distress Syndrome, Adult, 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 4 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 28 Apr 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?
Gas exchange and respiratory mechanics (time frame: 5 minutes). 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 28 Apr 2015.