NCT00453726

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 5, 2009

Status Verified

October 1, 2009

First QC Date

March 28, 2007

Last Update Submit

October 2, 2009

Conditions

Respiratory Insufficiency

Keywords

Natriuretic peptide brainContinuous positive airway pressureIntermittent positive pressure breathingRespiratory insufficiency

Interventions

Non invasive mechanical ventilationPROCEDURE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of the city of Torino, admitted to the emergency department for acute respiratory failure.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Giovanni Bosco Medicina d'Urgenza

Turin, Piedmont, 10154, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Giovanni Ferrari, MD

    Ospedale San Giovanni Bosco ASL4 Torino Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 29, 2007

Study Start

May 1, 2006

Study Completion

July 1, 2009

Last Updated

October 5, 2009

Record last verified: 2009-10

Locations

IT(1)