Chronic respiratory insufficiency and COPD are the third leading cause of death worldwide. Patients decompensate at various stages of their disease and exhibit acute-on-chronic respiratory failure (ACRF), a frequent cause of ICU hospitalization for hypercapnic acute respiratory failure (ARF). Non-invasive ventilation (NIV) is the first line ventilatory treatment for hypercapnic ARF. It is applied intermittently, separated by periods of spontaneous breathing (SB) with standard oxygen (O2). Standard O2 has drawbacks that limit the benefit of intermittent NIV in hypercapnic ARF: limited gas flow which is well below the patient's inspiratory flow rate, limited capacity and efficiency of oxygenation with non-controlled FiO2 (risk of excessive oxygen and induced hypercapnia), and cold and dry gas leading to discomfort and under-humidification of the airways and tracheobronchial secretions. Benefits in terms of work of breathing and CO2 removal resulting from PEEP and pressure support applied during NIV periods could be rapidly lost during standard O2. Recently, use of high-flow heated and humidified nasal oxygen therapy (HFHO) has gained enthusiasm among intensivists to manage ARF. HFHO delivers high flows (up to 60L/min, that generate moderate PEEP) of heated and humidified oxygen at a controlled and adjustable FiO2 (21 to 100%) that rapidly improve respiratory distress symptoms, oxygenation, respiratory comfort and outcome of patients with hypoxemic ARF. These unique features of HFHO could overcome some of the drawbacks of standard O2 during SB periods in hypercapnic ARF. Indeed, PEEP effect, washout of nasopharyngeal dead-space limiting CO2 re-breathing and inspired gas conditioning preserving adequate mucosal function and secretion removal, could potentially contribute to decrease airways resistance, intrinsic PEEP and work of breathing, while improving patient comfort. Investigators aim to determine if the use of HFHO, as compared to standard O2, increases the number of ventilator-free days (VFDs) and alive at day 28 in patients with hypercapnic ARF admitted in an ICU, an intermediate care, or a respiratory care unit, and requiring NIV.
In both groups, treatment will start with a first NIV session of 2 hours, with arterial blood gas measurement between one hour and two hours after initiating the NIV session. The NIV will be extended for those patients with a pH \< 7.30. In both groups, patients will be assessed for their tolerance of NIV and their ability to switch to spontaneous breathing every hour +/- 30 min, except during sleep (10 pm-8 am); they will be assessed for their tolerance of spontaneous breathing and for the need of resumption of NIV every 2 hours+/- 30 min and every 4 +/- 1 hours thereafter. To ensure the consistency of indications of NIV and invasive mechanical ventilation (IMV) across centers and reduce potential bias, NIV and IMV will be initiated and stopped in the same way in the two groups, using predefined criteria. * Inclusion (day 0): informed consent, randomisation (HFHO group/standard O2 group), NIV initiation (for 2 hours), clinical and paraclinical exam including ABG, data collection * Follow-up (day 1 to day 28) : NIV, clinical exam, ABG, data collection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
161
* Common name: humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases * Brand name: Airvo 2
Standard oxygen therapy
Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier
Colombes, France
Number of ventilator-free days (VFDs) alive
Time frame: At day 28 after study enrollment
Delay of completion of stopping rules for NIV
Time frame: 28 days post-randomisation
Patient self-assessement of comfort during each SB period measured by Visual Analog Scale (score range 0-10, higher values represent a better outcome)
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Nurse assessement of comfort during each SB period measured by Likert scale (score range1-5; higher values represent a better outcome)
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Hospital length of stay
Time frame: 28 days post-randomisation
All cause mortality
Time frame: 28 days post-randomisation
Proportion of patients with facial skin erythema and/or ulceration
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Number of NIV sessions
Time frame: 28 days post-randomisation
Duration of NIV sessions (hours)
Time frame: 28 days post-randomisation
Number of days between the day the patient first meets criteria for NIV cessation and day 28 post-randomization
Time frame: 28 days post-randomisation
Number of days between the day of initially achieving unassisted ventilation and day 28 post-randomization (i.e. after having successfully spent 48 consecutive hours of unassisted breathing)
Time frame: 28 days post-randomisation
Proportion of patients achieving 48 consecutive hours of daytime unassisted breathing
Time frame: 28 days post-randomisation
Proportion of patients requiring NIV resumption after 48 consecutive hours of daytime unassisted breathing
Time frame: 28 days post-randomisation
Patient self-assessement of comfort during each NIV period measured by Visual Analog Scale (score range 0-10, higher values represent a better outcome)
Time frame: after 1 hour of NIV, up to 28 days
Nurse assessement of comfort during each NIV period measured by Likert scale (score range1-5; higher values represent a better outcome)
Time frame: after 1 hour of NIV, up to 28 days
Patient self-assessement of dyspnea during each SB period measured by Visual Analog Scale (range 0-10; higher values represent a worst outcome)
Time frame: after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Nurse assessement of dyspnea during each SB period measured by Likert scale (score range1-5; higher values represent a worst outcome)
Time frame: after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Patient self-assessement of dyspnea during each NIV period measured by Visual Analog Scale (range 0-10; higher values represent a worst outcome)
Time frame: after 1 hour of NIV, up to 28 days
Nurse assessement of dyspnea during each NIV period measured by Likert scale (score range1-5; higher values represent a worst outcome)
Time frame: after 1 hour of NIV, up to 28 days
Respiratory rate during SB periods
Time frame: after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days
Respiratory rate during NIV periods
Time frame: after 1 hour of NIV, up to 28 days
Proportion of patients using accessory muscles during NIV periods
Time frame: after 1 hour of NIV, up to 28 days
Daily arterial blood gases (ABG) (in terms of pH, PaCO2 and PaO2 measured between 8-10 am).
Time frame: up to 28 days post-randomisation
Proportion of patients with premature NIV cessation (intolerance) (defined by agitation and/or mask removal, and/or patient's wish to interrupt session before)
Time frame: 28 days post-randomisation
Proportion of patients refusing to resume NIV (despite meeting criteria)
Time frame: 28 days post-randomisation
Proportion of patients who need secondary intubation and IMV
Time frame: 28 days post-randomisation
Proportion of patients with nasal bridge ulceration
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with eye irritation
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nasal congestion
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nasal/oral dryness
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with gastric distension
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nosocomial pneumonia
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with pneumothorax
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with arterial hypotension
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nostril ulceration (including nasolabial angle, columella, nostril sill)
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
Proportion of patients with nose bleeding
Time frame: After 2 hours of SB in the 48 first hours, and every 4 hours thereafter; and after 1 hour of NIV; up to 28 days
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