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Improving Non-invasive Ventilation (Improving NIV)

This study is currently recruiting participants.
Verified October 2012 by Università Vita-Salute San Raffaele
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01571986
First received: March 16, 2012
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

A single center, observational, prospective study to improve knowledge about non-invasive ventilation, obtaining data about compliance, efficacy, imaging in patients who already receive non-invasive ventilation as standard of care.


Condition Intervention
Acute Respiratory Failure
 Procedure: Non-invasive ventilation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Improving Non Invasive Ventilation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Number of patients requiring NIV in a large university hospital. Incidence of NIV failure (including patient compliance) and NIV related complications. Imaging (chest ultrasound) in a subgroup of patients before and after receiving NIV. [ Time Frame: Outcome measures will be assessed every day and participants will be followed for the duration of hospital stay, an expected average of 1 weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: February 2012
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NIV
All patients with acute respiratory failure treated with non-invasive ventilation who give informed consent about treatment of their clinical data
 Procedure: Non-invasive ventilation
Non-invasive ventilation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients with acute respiratory failure treated with non-invasive ventilation who give informed consent about treatment of their clinical data

Criteria

Inclusion Criteria:

  • treatment with non-invasive ventilation
  • informed consent

Exclusion Criteria:

  • refusal of informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571986

Contacts
Contact: Luca Cabrini, MD cabrini.luca@hsr.it

Locations
Italy
Ospedale San Raffaele di Milano Recruiting
Milano, Italy, 20132
Contact: Luca Cabrini         cabrini.luca@hsr.it    
Sponsors and Collaborators
Università Vita-Salute San Raffaele
  More Information

No publications provided

Responsible Party: Giovanni Landoni, Principal Investigator, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01571986     History of Changes
Other Study ID Numbers: VP/50/ER/mm
Study First Received: March 16, 2012
Last Updated: October 11, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
NIV
acute respiratory failure
hypoxia
 hypercapnia
non-invasive ventilation
hospital ward

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 16, 2013