Clinical Trial

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

Study acronym: NIV-ICU
Not Yet Recruiting
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-14.
Trial Details
NCT Number NCT06888180
Lead Sponsor University Hospital, Caen
Conditions COPD (Chronic Obstructive Pulmonary Disease), Acute Exacerbation of COPD, Hypercapnic Respiratory Failure, COPD
Enrollment 976 participants
Start Date 2025-09
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-03-26