Survey on NIV Settings in the Intensive Care Unit for Acute Exacerbation of COPD (NIV-ICU)

March 24, 2025 updated by: University Hospital, Caen

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

976

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COPD Patients Admitted to Critical Care for Hypercapnic Respiratory Distress

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COPD patients managed with NIV during acute exacerbation
Other: Non interventional study
Documentation of Non-Invasive Ventilation Settings at Different Stages of Patient Management"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ventilatory Settings at Initiation of Non-Invasive Ventilation Upon ICU Admission
Time Frame: Upon ICU admission
Upon ICU admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: at 28 days
at 28 days
Ventilatory Settings at Initiation of Non-Invasive Ventilation at 24h of ICU Admission
Time Frame: 24hours from ICU admission
24hours from ICU admission
Ventilatory Settings at 48 Hours After Initiation of Non-Invasive Ventilation in the ICU
Time Frame: 48hours after ICU admission
48hours after ICU admission
arterial blood gaz
Time Frame: Upon ICU admission, 24hours after ICU admission, 48hours after admission
Upon ICU admission, 24hours after ICU admission, 48hours after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024120510170200000180001753

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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