High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease. (OxyCOD)

Centre Hospitalier Régional d'Orléans

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Noninvasive ventilation; Other: High-Flow Nasal Oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03488628

CHRO-2017-16

ID RCB: 2017-A03535-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Noninvasive ventilation

Active Comparator group

Description:

Noninvasive ventilation delivered through a face mask, in alternance with standard nasal oxygen therapy

Treatment:

Other: Noninvasive ventilation

High-Flow Nasal Oxygen therapy

Experimental group

Description:

High-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher \& Paykel Healthcare,New Zealand) through nasal canula.

Treatment:

Other: High-Flow Nasal Oxygen therapy