COPD (Chronic Obstructive Pulmonary Disease)NIV-ICUNCT06888180
Survey on NIV Settings in the Intensive Care Unit for Acute Exacerbation of COPD
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Acute Exacerbation of COPD, run by University Hospital, Caen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Acute Exacerbation of COPD, Hypercapnic Respiratory Failure, COPD
- What is being tested?
- Non interventional study
- How many people
- 976 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD Patients Admitted to Critical Care for Hypercapnic Respiratory Distress
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Acute Exacerbation of COPD, Hypercapnic Respiratory Failure, COPD
- Being tested
- Non interventional study
- Keywords
- COPD, Acute exacerbation of COPD, Non invasive ventilation, Hypercapnic respiratory failure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
Documentation of Non-Invasive Ventilation Settings at Different Stages of Patient Management"
| Study group | Role | What they receive |
|---|---|---|
| COPD patients managed with NIV during acute exacerbation | Not described Receives: Other: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory Settings at Initiation of Non-Invasive Ventilation Upon ICU Admission
Measured: Upon ICU admission
Secondary outcomes (4)
Ventilatory Settings at Initiation of Non-Invasive Ventilation at 24h of ICU Admission
Measured: 24hours from ICU admission
Ventilatory Settings at 48 Hours After Initiation of Non-Invasive Ventilation in the ICU
Measured: 48hours after ICU admission
arterial blood gaz
Measured: Upon ICU admission, 24hours after ICU admission, 48hours after admission
Mortality
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 976 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888180
- Sponsor's protocol ID
- 2024120510170200000180001753
- Acronym
- NIV-ICU
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Non-Invasive Ventilation Settings in the Intensive Care Unit for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06888180
- Acronym / sponsor ID
- NIV-ICU / 2024120510170200000180001753
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 976 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients managed with NIV during acute exacerbation | – | Other: Non interventional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD Patients Admitted to Critical Care for Hypercapnic Respiratory Distress
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventional studyDocumentation of Non-Invasive Ventilation Settings at Different Stages of Patient Management" | Other | COPD patients managed with NIV during acute exacerbation |
Primary outcome
Ventilatory Settings at Initiation of Non-Invasive Ventilation Upon ICU Admission
Time frame: Upon ICU admission
4 secondary outcomes
Ventilatory Settings at Initiation of Non-Invasive Ventilation at 24h of ICU Admission
Time frame: 24hours from ICU admission
Ventilatory Settings at 48 Hours After Initiation of Non-Invasive Ventilation in the ICU
Time frame: 48hours after ICU admission
arterial blood gaz
Time frame: Upon ICU admission, 24hours after ICU admission, 48hours after admission
Mortality
Time frame: at 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Acute Exacerbation of COPD, run by University Hospital, Caen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Cuchet, Medical degree (+33231065318, cuchet-p@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory Settings at Initiation of Non-Invasive Ventilation Upon ICU Admission (time frame: Upon ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.