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NCT01571986 Clinical Trial

Improving Non-invasive Ventilation

Acute Respiratory Failure Clinical Trial

— Improving NIV  

Official title:
Improving Non Invasive Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01571986
Other study ID # VP/50/ER/mm
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2012
Est. completion date May 2025

Study information
Verified date January 2024
Source Università Vita-Salute San Raffaele
Contact Luca Cabrini, MD
Email cabrini.luca@hsr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 750
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - treatment with non-invasive ventilation - informed consent Exclusion Criteria: - refusal of informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Non-invasive ventilation
Non-invasive ventilation

Locations
Country Name City State
Italy Ospedale San Raffaele di Milano Milano

Sponsors (1)
Lead Sponsor Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Cabrini L, Nobile L, Plumari VP, Landoni G, Borghi G, Mucchetti M, Zangrillo A. Intraoperative prophylactic and therapeutic non-invasive ventilation: a systematic review. Br J Anaesth. 2014 Apr;112(4):638-47. doi: 10.1093/bja/aet465. Epub 2014 Jan 19. — View Citation

Cabrini L, Plumari VP, Nobile L, Olper L, Pasin L, Bocchino S, Landoni G, Beretta L, Zangrillo A. Non-invasive ventilation in cardiac surgery: a concise review. Heart Lung Vessel. 2013;5(3):137-41. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Outcome measures will be assessed every day and participants will be followed for the duration of hospital stay, an expected average of 1 weeks.
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