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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

COPD Patients Admitted to Critical Care for Hypercapnic Respiratory Distress

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non interventional study

    Other intervention

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

Treatment groups

976 Participants
are divided into 1 treatment group
Group A: COPD patients managed with NIV during acute exacerbation1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: