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NCT Number: NCT06888180

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

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).

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Acute Exacerbation of COPD Chronic Disease Disease Attributes Hypercapnic Respiratory Failure, COPD Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non interventional study

Other

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

Primary outcomes

  1. Ventilatory Settings at Initiation of Non-Invasive Ventilation Upon ICU Admission

    Time frame: Upon ICU admission

Secondary outcomes

  1. Ventilatory Settings at Initiation of Non-Invasive Ventilation at 24h of ICU Admission

    Time frame: 24hours from ICU admission

  2. Ventilatory Settings at 48 Hours After Initiation of Non-Invasive Ventilation in the ICU

    Time frame: 48hours after ICU admission

  3. arterial blood gaz

    Time frame: Upon ICU admission, 24hours after ICU admission, 48hours after admission

  4. Mortality

    Time frame: at 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Cuchet, Medical degree

CONTACT

[email protected]

+33231065318

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: NIV-ICU

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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