Respiratory Distress Syndrome, AdultPhase 3NCT00465374
A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients
A Phase 3 study testing Change ventilatory parameters with stress index monitoring in people with Respiratory Distress Syndrome, Adult, run by University of Turin, Italy at 1 site in Italy.
Trial summary
30% of ARDS patients ventilated according to NIH protocol presents CT scan evidence of hyperinflation. Functional analysis of pressure-time curve (Stress Index=SI) has been shown to identify this condition in experimental settings. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Change ventilatory parameters with stress index monitoring
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Oct 2002to not given
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of ARDS based on American-European Consensus Conference criteria
Who cannot join
- >3 days since ARDS criteria were met and mechanical ventilation was started
- History of ventricular fibrillation or tachyarrhythmia, unstable angina or myocardial infarction within preceding month
- Pre-existing chronic obstructive pulmonary disease
- Major chest wall abnormalities
- Chest tube with persistent air leak
- Abdominal distension
Show all 10Show fewer
- Body mass index >30
- Pregnancy
- Known intracranial abnormality
- Enrollment in another interventional study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Turin, Department of Anesthesia and Intensive Care Medicine
Turin
V. M. Ranieri, MD, +390116334001, marco.ranieri@unito.it
P. Terragni, MD, +390116334002, pierpaolo.terragni@unito.it
About this study
30% of ARDS patients ventilated according to NIH protocol presents CT scan evidence of hyperinflation. Functional analysis of pressure-time curve (Stress Index=SI) has been shown to identify this condition in experimental settings. We tested the hypothesis that the SI is an accurate predictor of mechanical stress due to overdistention in ARDS patients.
Read the detailed description
The study presents two parts : a preliminary validation study and a clinical study.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Change ventilatory parameters with stress index monitoring
- Keywords
- ARDS, Pressure/time curve, Stress Index
- 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.
Change ventilatory parameters with stress index monitoringProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of pulmonary inflammatory mediators
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Investigators
- V. M. Ranieri, MD, Study director, University of Turin, ItalyP. Terragni, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465374
- Sponsor's protocol ID
- PRN60ANRA04
- Status last verified
- Apr 2007
- First submitted
- 24 Apr 2007
- Last updated
- 25 Apr 2007
- Results posted
- No
Publications
Ranieri VM, Zhang H, Mascia L, Aubin M, Lin CY, Mullen JB, Grasso S, Binnie M, Volgyesi GA, Eng P, Slutsky AS. Pressure-time curve predicts minimally injurious ventilatory strategy in an isolated rat lung model. Anesthesiology. 2000 Nov;93(5):1320-8. doi: 10.1097/00000542-200011000-00027.
PubMed 11046222Grasso S, Terragni P, Mascia L, Fanelli V, Quintel M, Herrmann P, Hedenstierna G, Slutsky AS, Ranieri VM. Airway pressure-time curve profile (stress index) detects tidal recruitment/hyperinflation in experimental acute lung injury. Crit Care Med. 2004 Apr;32(4):1018-27. doi: 10.1097/01.ccm.0000120059.94009.ad.
PubMed 15071395
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients
- ClinicalTrials.gov ID
- NCT00465374
- Acronym / sponsor ID
- PRN60ANRA04
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- ARDS, Pressure/time curve, Stress Index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Oct 2002
- First posted
- 25 Apr 2007 (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.
30% of ARDS patients ventilated according to NIH protocol presents CT scan evidence of hyperinflation. Functional analysis of pressure-time curve (Stress Index=SI) has been shown to identify this condition in experimental settings. We tested the hypothesis that the SI is an accurate predictor of mechanical stress due to overdistention in ARDS patients.
Detailed description
The study presents two parts : a preliminary validation study and a clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Diagnosis of ARDS based on American-European Consensus Conference criteria
Key exclusion criteria (10 listed)
- >3 days since ARDS criteria were met and mechanical ventilation was started
- History of ventricular fibrillation or tachyarrhythmia, unstable angina or myocardial infarction within preceding month
- Pre-existing chronic obstructive pulmonary disease
- Major chest wall abnormalities
- Chest tube with persistent air leak
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 |
|---|---|---|
| Change ventilatory parameters with stress index monitoring | Procedure or surgery | – |
Primary outcome
reduction of pulmonary inflammatory mediators
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2007.
- Background: PubMed 11046222Ranieri VM, Zhang H, Mascia L, Aubin M, Lin CY, Mullen JB, Grasso S, Binnie M, Volgyesi GA, Eng P, Slutsky AS. Pressure-time curve predicts minimally injurious ventilatory strategy in an isolated rat lung model. Anesthesiology. 2000 Nov;93(5):1320-8. doi: 10.1097/00000542-200011000-00027.
- Background: PubMed 15071395Grasso S, Terragni P, Mascia L, Fanelli V, Quintel M, Herrmann P, Hedenstierna G, Slutsky AS, Ranieri VM. Airway pressure-time curve profile (stress index) detects tidal recruitment/hyperinflation in experimental acute lung injury. Crit Care Med. 2004 Apr;32(4):1018-27. doi: 10.1097/01.ccm.0000120059.94009.ad.
Related trials for Respiratory Distress Syndrome, Adult
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruitingPhase 2
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
Acute Respiratory Distress Syndrome, ARDS
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingPhase 3
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
Allogeneic Stem Cell Transplantation, Lung Allograft Transplantation
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.
V. M. Ranieri, MD study director
University of Turin, Italy
P. Terragni, MD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Change ventilatory parameters with stress index monitoring in people with Respiratory Distress Syndrome, Adult, run by University of Turin, Italy 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 25 Apr 2007. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact V. M. Ranieri, MD (00390116334001, marco.ranieri@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of pulmonary inflammatory mediators. 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 NCT00465374, which also lists 2 linked publications.
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 Apr 2007.