Use of Nasal High Flow Oxygen During Breaks of Non-invasive Ventilation for Patients With Hypercapnic Respiratory Failure
- Conditions
- Hypercapnic Respiratory Failure
- Interventions
- Device: HFHO GroupDevice: Standard O2
- Registration Number
- NCT03406572
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HFHO Group HFHO Group Patients will receive a first NIV session (for 2 hours) with predefined parameters, and ABG will be performed between one and two hours of starting NIV. NIV will be extended according to ABG result (i.e. extended if pH \< 7.30). Switch from NIV to oxygen will require predefined criteria. In-between each NIV session, oxygen will be delivered using a high flow nasal cannula, with a flow of 50-60L/min and a FiO2 set to reach a targeted SpO2: 88%≤SpO2 ≤ 92%. Predefined criteria will be used to resume NIV. Standard O2 Group Standard O2 NIV will be initiated based on the same criteria and with the same parameters as the HFHO group. ABG will also be performed between one and two hours and NIV extended according to ABG result (i.e. extended if pH \< 7.30). Switch from NIV to oxygen will require the same predefined criteria as the HFHO group. In-between each NIV session, oxygen will be delivered using standard low flow O2 to reach the same targeted SpO2: 88% ≤SpO2 ≤ 92%. Similar criteria will be used to resume NIV
- Primary Outcome Measures
Name Time Method Number of ventilator-free days (VFDs) alive At day 28 after study enrollment
- Secondary Outcome Measures
Name Time Method Number of NIV sessions 28 days post-randomisation Hospital length of stay 28 days post-randomisation All cause mortality 28 days post-randomisation Duration of NIV sessions (hours) 28 days post-randomisation Number of days between the day the patient first meets criteria for NIV cessation and day 28 post-randomization 28 days post-randomisation Proportion of patients requiring NIV resumption after 48 consecutive hours of daytime unassisted breathing 28 days post-randomisation Patient self-assessement of dyspnea during each SB period measured by Visual Analog Scale (range 0-10; higher values represent a worst outcome) after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days Respiratory rate during SB periods after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days Proportion of patients with nasal congestion 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 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 Delay of completion of stopping rules for NIV 28 days post-randomisation Nurse assessement of comfort during each SB period measured by Likert scale (score range1-5; higher values represent a better outcome) 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) after 2 hours of SB in the 48 first hours, and every 4 hours thereafter, up to 28 days Respiratory rate during NIV periods after 1 hour of NIV, up to 28 days Proportion of patients with premature NIV cessation (intolerance) (defined by agitation and/or mask removal, and/or patient's wish to interrupt session before) 28 days post-randomisation Proportion of patients with nasal bridge ulceration 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 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 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 Patient self-assessement of comfort during each SB period measured by Visual Analog Scale (score range 0-10, higher values represent a better outcome) 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) after 1 hour of NIV, up to 28 days Proportion of patients who need secondary intubation and IMV 28 days post-randomisation Proportion of patients with nose bleeding 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 facial skin erythema and/or ulceration 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 achieving 48 consecutive hours of daytime unassisted breathing 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) 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) after 1 hour of NIV, up to 28 days 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) 28 days post-randomisation Nurse assessement of comfort during each NIV period measured by Likert scale (score range1-5; higher values represent a better outcome) after 1 hour of NIV, up to 28 days Proportion of patients using accessory muscles during NIV periods 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). up to 28 days post-randomisation Proportion of patients with nasal/oral dryness 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 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 refusing to resume NIV (despite meeting criteria) 28 days post-randomisation Proportion of patients with gastric distension 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) 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
Trial Locations
- Locations (1)
Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier
🇫🇷Colombes, France