Improving Non-invasive Ventilation (Improving NIV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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 2, 2014
Last verified: October 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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 2, 2014
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 Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on October 19, 2014