NCT01571986

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

14.3 years

First QC Date

March 16, 2012

Last Update Submit

June 26, 2025

Conditions

Keywords

NIVacute respiratory failurehypoxiahypercapnianon-invasive ventilationhospital ward

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

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

Interventions

Non-invasive ventilation

NIV

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • treatment with non-invasive ventilation
  • informed consent

You may not qualify if:

  • refusal of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Raffaele di Milano

Milan, 20132, Italy

RECRUITING

Related 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.

    PMID: 24444661BACKGROUND
  • 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.

    PMID: 24364004BACKGROUND

MeSH Terms

Conditions

HypoxiaHypercapnia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Central Study Contacts

Luca Cabrini, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2012

First Posted

April 5, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

July 1, 2025

Record last verified: 2025-06

Locations