Respiratory InsufficiencyNCT00453726
Brain Natriuretic Peptide (BNP) Levels in Patients in Non Invasive Mechanical Ventilation
An observational study of Respiratory Insufficiency, run by Ospedale S. Giovanni Bosco at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate variation of BNP in non invasive mechanical ventilated patients with severe acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Non invasive mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- May 2006to Jul 2009
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the city of Torino, admitted to the emergency department for acute respiratory failure.
Who may be able to join
- Severe respiratory distress (use of respiratory accessory muscles);
- Respiratory rate > 25 per minute;
- Respiratory acidosis (pH < 7.35 and PaCO2 > 45 mmHg);
- PaO2/FiO2 < 250
Who cannot join
- Age < 18 years;
- Facial deformities;
- Pneumothorax;
- Shock or systolic arterial pressure below 90 mmHg with amine infusion;
- Life-threatening arrhythmias;
- Need for immediate endotracheal intubation (PaO2/FiO2 < 100 with FiO2 100%, respiratory rate < 10, GCS < 8);
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- Lack of co-operation from the patient;
- Recent esophageal-gastric surgery;
- Inability to clear secretions;
- Drugs that may interfere with BNP secretion;
- Severe obesity;
- Hepatic cirrhosis with ascitis;
- Endocrine disease.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale San Giovanni Bosco Medicina d'Urgenza
Turin, Piedmont, 10154
About this study
Official title: Evaluation of BNP in Patients With Severe Acute Respiratory Failure Requiring Non Invasive Mechanical Ventilation
The purpose of the study is to evaluate variation of BNP in non invasive mechanical ventilated patients with severe acute respiratory failure.
Read the detailed description
The aim of the study is to evaluate in patients with severe acute respiratory failure requiring non invasive mechanical ventilation BNP levels at admission and during the following 24 hours during non invasive mechanical ventilation (Non Invasive Positive Pressure Ventilation or Continuous positive airway pressure).
Because in patients affected by acute respiratory failure it is often difficult to distinguish if the disease precipitating the respiratory failure is a cardiac disease or a lung disease, aim of the present study is to evaluate the discriminating role that BNP could have in this group of patients; evaluation will be completed, once obtained clinical stabilisation, with an echocardiography and respiratory functional test.
- Conditions
- Respiratory Insufficiency
- Being tested
- Non invasive mechanical ventilation
- Keywords
- Natriuretic peptide brain, Continuous positive airway pressure, Intermittent positive pressure breathing, Respiratory insufficiency
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive mechanical ventilationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startMay 2006
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- Ospedale S. Giovanni Bosco
- Sponsor type
- University, hospital or other
- Investigators
- Giovanni Ferrari, MD, Principal investigator, Ospedale San Giovanni Bosco ASL4 Torino Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453726
- Sponsor's protocol ID
- gbosco3
- Status last verified
- Oct 2009
- First submitted
- 28 Mar 2007
- Last updated
- 5 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of BNP in Patients With Severe Acute Respiratory Failure Requiring Non Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00453726
- Acronym / sponsor ID
- gbosco3
- Conditions
- Respiratory Insufficiency
- Keywords
- Natriuretic peptide brain, Continuous positive airway pressure, Intermittent positive pressure breathing, Respiratory insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ospedale S. Giovanni BoscoUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Mar 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.
The purpose of the study is to evaluate variation of BNP in non invasive mechanical ventilated patients with severe acute respiratory failure.
Detailed description
The aim of the study is to evaluate in patients with severe acute respiratory failure requiring non invasive mechanical ventilation BNP levels at admission and during the following 24 hours during non invasive mechanical ventilation (Non Invasive Positive Pressure Ventilation or Continuous positive airway pressure).
Because in patients affected by acute respiratory failure it is often difficult to distinguish if the disease precipitating the respiratory failure is a cardiac disease or a lung disease, aim of the present study is to evaluate the discriminating role that BNP could have in this group of patients; evaluation will be completed, once obtained clinical stabilisation, with an echocardiography and respiratory functional test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the city of Torino, admitted to the emergency department for acute respiratory failure.
Key inclusion criteria (4 listed)
- Severe respiratory distress (use of respiratory accessory muscles);
- Respiratory rate > 25 per minute;
- Respiratory acidosis (pH < 7.35 and PaCO2 > 45 mmHg);
- PaO2/FiO2 < 250
Key exclusion criteria (13 listed)
- Age < 18 years;
- Facial deformities;
- Pneumothorax;
- Shock or systolic arterial pressure below 90 mmHg with amine infusion;
- Life-threatening arrhythmias;
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 |
|---|---|---|
| Non invasive mechanical ventilation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 5 Oct 2009.
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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.
Giovanni Ferrari, MD principal investigator
Ospedale San Giovanni Bosco ASL4 Torino Italy
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 Respiratory Insufficiency, run by Ospedale S. Giovanni Bosco 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 4 inclusion and 13 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 5 Oct 2009. 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.
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 5 Oct 2009.