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

NCT06888180 | Not Yet Recruiting

• 1 other identifier: 2024120510170200000180001753
• Study Type: observational
• Target: 976
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Upon ICU admission

Secondary Outcomes (4)

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

  24hours from ICU admission

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

  48hours after ICU admission

• arterial blood gaz

  Upon ICU admission, 24hours after ICU admission, 48hours after admission

• Mortality

  at 28 days

Study Arms (1)

COPD patients managed with NIV during acute exacerbation

Other: Non interventional study

Interventions

Non interventional study OTHER

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

COPD patients managed with NIV during acute exacerbation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD Patients Admitted to Critical Care for Hypercapnic Respiratory Distress

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Central Study Contacts

Pierre Cuchet, Medical degree

CONTACT

+33231065318; cuchet-p@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03