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Not Yet RecruitingNCT06888180

Survey on NIV Settings in the Intensive Care Unit for Acute Exacerbation of COPD

Survey on Non-Invasive Ventilation Settings in the Intensive Care Unit for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
976 (estimated)
Sponsor
University Hospital, Caen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Introduction Chronic obstructive pulmonary disease (COPD) is a common condition and the fourth leading cause of death worldwide. With the rise of non-invasive ventilation (NIV), mortality among patients admitted for acute hypercapnic respiratory failure has decreased, though to a lesser extent than reported in the studies that validated this technique. We hypothesize that inappropriate initial ventilatory parameter settings for NIV could be associated with increased morbidity and mortality in this context. Objective The primary objective of this study is to assess the initial NIV settings used in intensive care units (ICUs) and respiratory intensive care or medical intensive care units (MICUs) in this patient population. A secondary objective is to evaluate whether specific ventilatory settings are associated with mortality or the need for invasive mechanical ventilation (IMV). Methods This is a prospective multicenter observational study aiming to include 976 patients. NIV settings will be recorded at initiation, after the first recommended arterial blood gas (ABG) evaluation (between 1.5 and 2 hours of ventilation), and at 24 and 48 hours. Patient characteristics, including medical history, clinical and biological parameters at admission, will be collected. Vital status and the need for IMV will be recorded at ICU discharge and on day 28 (D28).

Conditions

Interventions

TypeNameDescription
OTHERNon interventional studyDocumentation of Non-Invasive Ventilation Settings at Different Stages of Patient Management"

Timeline

Start date
2025-09-01
Primary completion
2027-09-01
Completion
2027-09-01
First posted
2025-03-21
Last updated
2025-03-26

Source: ClinicalTrials.gov record NCT06888180. Inclusion in this directory is not an endorsement.