Clinical trial NCT03488628: High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease.
Official title: High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease: A Randomized, Open-label, Single-center, Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: respiratory failure
oxygen therapy
Noninvasive ventilation
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High-Flow Nasal Oxygen (HFNO) therapy has never been tested against Noninvasive ventilation, the reference standard therapy for acute exacerbation of chronic obstructive pulmonary disease (COPD), in randomized clinical trials.

The aim of the present study is to compare the effects of HFNO therapy on arterial blood gas variables over the first 24 hours of therapy, to those of Noninvasive ventilation, in patients experiencing a moderate (i.e. with arterial pH within 7.25-7.35) exacerbation of COPD.

Detailed description: As soon as admission to the intensive care unit, eligible patients who gave consent will be randomized to either HFNO or Noninvasive ventilation therapy for at least the first 24 hours.

In the usual care group , Noninvasive ventilation will be applied in alternance with standard nasal oxygen therapy.

In the intervention group, HFNO with be applied continuously over the first 24 hours.

In both groups, an oxygen saturation, as assessed by finger pulse oximetry, of 88-92% will be targeted.

The primary objective will be two-fold: to compare between groups 1) Efficacy, assessed by the arterial pH at 24 hours, and 2) Safety, assessed by the ratio of the arterial partial pressure in oxygen (PaO2) over the inspired oxygen fraction (FiO2) at 24 hours.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Known Chronic Obstructive Pulmonary disease (COPD)
* respiratory rate or presence of accessory respiratory muscles activity on physical exam
* moderate exacerbation of COPD as defined by an arteria pH between 7.25 and 7.35 and an arterial carbon dioxide partial pressure (PaCO2) equal or above 45 mm Hg

Exclusion Criteria:

* Age below 18
* Pregnancy
* Known sleep apnea syndrome
* Patent treated by noninvasive ventilation at home
* Not affiliated to French scial security
* Contraindication to aither Noninvasive ventilation or to High-Flow Nasal Oxygen therapy
* Previous inclusion in the study

Primary outcomes:
measure: Arterial pH at 24 hours
timeFrame: 24 hours
measure: PaO2/FiO2 ratio at 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Cumulative incidence of tracheal intubation
timeFrame: 28 days
measure: Time course of arterial pH
timeFrame: 24 hours
measure: Arterial partial pressure in carbon dioxide (PaCO2)
timeFrame: 24 hours
measure: Time course of arterial oxygen saturation (SaO2)
timeFrame: 24 hours
measure: Self-reported dyspnea score
timeFrame: 24 hours
measure: Perceived nursing workload
timeFrame: 24 hours
measure: Proportion of patients who will need Noninvasive ventilation in the High-Flow Nasal Oxygen group from randomisation through the 24th hour
timeFrame: 24 hours
measure: Severe Adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
affiliation: Centre Hospitalier Régional d'Orléans
name: Mai-Anh Nay, MD
role: PRINCIPAL_INVESTIGATOR
References: