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

Respiratory Insufficiency Clinical Trial

Official title:

Evaluation of BNP in Patients With Severe Acute Respiratory Failure Requiring Non Invasive Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453726
• Other study ID #: gbosco3
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2007
• Last updated: October 2, 2009
• Start date: May 2006
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: Ospedale S. Giovanni Bosco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Procedure:
• Non invasive mechanical ventilation

Locations

Country	Name	City	State
Italy	Ospedale San Giovanni Bosco Medicina d'Urgenza	Torino	Piedmont

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale S. Giovanni Bosco

Country where clinical trial is conducted

Italy,