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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06888180
Acronym
NIV-ICU
Enrollment
976
Registered
2025-03-21
Start date
2025-09-30
Completion date
2027-09-30
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation of COPD, COPD (Chronic Obstructive Pulmonary Disease), Hypercapnic Respiratory Failure, COPD

Keywords

COPD, Acute exacerbation of COPD, Non invasive ventilation, Hypercapnic respiratory failure

Brief 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).

Interventions

OTHERNon interventional study

Documentation of Non-Invasive Ventilation Settings at Different Stages of Patient Management

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult COPD Patient * Known or suspected COPD diagnosis as assessed by the attending physicians * Admitted to a medical intensive care unit (MICU), respiratory intensive care unit, or MICU * Hypercapnic respiratory distress * NIV indication determined by the physician * Covered by social security

Exclusion criteria

* Pregnant or breastfeeding women * Other obstructive diseases (asthma, bronchiectasis, cystic fibrosis, bronchiolitis, pulmonary fibrosis, restrictive thoracic syndrome) Central hypoventilation (Ondine's syndrome, iatrogenic), neurological (neuromuscular disease), osteoarticular (kyphoscoliosis), or ENT-related causes * Immediate need for intubation * Acute pulmonary edema * Contraindications to NIV (untreated pneumothorax, shock, cardiac arrest, uncontrolled vomiting, upper gastrointestinal bleeding, cervicofacial trauma, coma except when related to hypercapnia) * Patients under legal guardianship * Incarcerated individuals

Design outcomes

Primary

MeasureTime frame
Ventilatory Settings at Initiation of Non-Invasive Ventilation Upon ICU AdmissionUpon ICU admission

Secondary

MeasureTime frame
Ventilatory Settings at Initiation of Non-Invasive Ventilation at 24h of ICU Admission24hours from ICU admission
Ventilatory Settings at 48 Hours After Initiation of Non-Invasive Ventilation in the ICU48hours after ICU admission
arterial blood gazUpon ICU admission, 24hours after ICU admission, 48hours after admission
Mortalityat 28 days

Contacts

Primary ContactPierre Cuchet, Medical degree
cuchet-p@chu-caen.fr+33231065318

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026