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

This study has been completed.

Sponsor:

Information provided by:

Ospedale S. Giovanni Bosco

ClinicalTrials.gov Identifier:

NCT00453726

First received: March 28, 2007

Last updated: October 2, 2009

Last verified: October 2009

History of Changes

Purpose

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

Condition	Intervention	Phase
Respiratory Insufficiency	Procedure: Non invasive mechanical ventilation	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Evaluation of BNP in Patients With Severe Acute Respiratory Failure Requiring Non Invasive Mechanical Ventilation

Resource links provided by NLM:

MedlinePlus related topics: Respiratory Failure

U.S. FDA Resources

Further study details as provided by Ospedale S. Giovanni Bosco:

Estimated Enrollment:	40
Study Start Date:	May 2006
Study Completion Date:	July 2009

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Giovanni Ferrari, ASL TO4 Ospedale S. Giovanni Bosco
ClinicalTrials.gov Identifier:	NCT00453726 History of Changes
Other Study ID Numbers:	gbosco3
Study First Received:	March 28, 2007
Last Updated:	October 2, 2009
Health Authority:	Italy: Ministry of Health

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
Respiration Disorders
Respiratory Tract Diseases
Natriuretic Peptide, Brain
Natriuretic Agents

Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

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