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Brain Natriuretic Peptide (BNP) Levels in Patients in Non Invasive Mechanical Ventilation

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ClinicalTrials.gov Identifier: NCT00453726
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : October 5, 2009
Sponsor:
Information provided by:
Ospedale S. Giovanni Bosco

Brief Summary:
The purpose of the study is to evaluate variation of BNP in non invasive mechanical ventilated patients with severe acute respiratory failure.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Procedure: Non invasive mechanical ventilation Phase 4

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 Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of BNP in Patients With Severe Acute Respiratory Failure Requiring Non Invasive Mechanical Ventilation
Study Start Date : May 2006
Study Completion Date : July 2009

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients of the city of Torino, admitted to the emergency department for acute respiratory failure.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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);
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453726


Locations
Italy
Ospedale San Giovanni Bosco Medicina d'Urgenza
Torino, Piedmont, Italy, 10154
Sponsors and Collaborators
Ospedale S. Giovanni Bosco
Investigators
Principal Investigator: Giovanni Ferrari, MD Ospedale San Giovanni Bosco ASL4 Torino Italy

Responsible Party: Giovanni Ferrari, ASL TO4 Ospedale S. Giovanni Bosco
ClinicalTrials.gov Identifier: NCT00453726     History of Changes
Other Study ID Numbers: gbosco3
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: October 5, 2009
Last Verified: October 2009

Keywords provided by Ospedale S. Giovanni Bosco:
Natriuretic peptide brain
Continuous positive airway pressure
Intermittent positive pressure breathing
Respiratory insufficiency

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases