An interventional study of standard oxygen and HFNO in Acute Respiratory Failure, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-24.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask [with or without a bag and with or without the Venturi system] to achieve SpO2≥95%.
Oxygen therapy may be combined with non-invasive ventilation [NIV] providing both end-expiratory positive pressure and pressure support. However, in a recent trial by our group, non-invasive ventialtion [NIV] was not superior over oxygen without NIV.
High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with Fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.
Clinical consequences of these physiological benefits include alleviation of dyspnoea and discomfort, decreases in tachypnoea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.
Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimising day-28 mortality
After discussion at the investigator meeting and based on comments from the Data and Safety Monitoring Board on May 12, 2016, the DSMB has highlighted the need of the interim analysis (already planned) as benefits from high flow oxygen may be observed after 400 inclusions.
Update on June 16, 2017:
The number of patients enrolled is 488 and the inclusion rate is increasing steadily.
The interim analysis has been performed as scheduled and the DSMB decided that nothing should be changed.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 776 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
After discussion at the investigator meeting and based on comments from the Data and Safety Monitoring Board on May 12, 2016, as all included patients need to have an acute hypoxemic respiratory failure and at least 6l of oxygen per minute, patients admitted to the ICU to secure any procedure (bronchoscopy etc..) or those not admitted for acute respiratory failure and who undergo intubation, will NOT be included in this trial. Only patients meeting criteria of acute respiratory failure will be included in this trial.
Oxygen therapy will be delivered using any device or combination of devices that are part of usual care: nasal oxygen, and mask with or without a reservoir bag and with or without the Venturi system
Procedure: standard oxygen
Device that delivers humidified and warmed high-flow oxygen at flows greater than 15 L/min. HFNO will be initiated at a flow rate of 50 L/min and 100% FiO2. If the target SpO2 is not reached, the flow rate will be increased to 60 L/min. Then, FiO2 will be tapered to target an SpO2≥95. The minimal flow rate will be 45 L/min
Procedure: HFNO
Devices used to treat spontaneously ventilating patients in the ICU who require supplemental oxygen. They deliver either * low-flow oxygen \[including nasal cannula, Ventimask® without Venturi effect, and non-rebreather mask\] * or medium-flow oxygen \[Venturi masks and medium-flow facemasks\]
The intervention is the use of a device that allows to deliver high flow humidified and warmed oxygen. The device used is the Optiflow™ (Fisher\&Paykel, Courtaboeuf, France).
All-cause day-28 mortality
Time frame: 28 days
Intubation or reintubation rate
proportion of patients requiring invasive mechanical ventilation
Time frame: days 3 and 28
patient comfort
Visual Analogue Scale (VAS) score
Time frame: 28 days
Intensity of dyspnoea
Visual Analogue Scale (VAS) score
Time frame: days 1-3
Perceived Exertion
Borg scale
Time frame: days 1-3
Respiratory rate
Time frame: days 1-3
Oxygenation
based on continuous saturation of peripheral oxygen (SpO2) monitoring, lowest SpO2 from D1 to D3 and PaO2/FiO2 on D1, D2, and D3
Time frame: days 1-3
ICU length of stay
Time frame: 28 days
Incidence of ICU-acquired infections
Time frame: 28 days
Time to clear pulmonary infiltrates
Murray score
Time frame: 28 days
Oxygen-free and ventilation-free survivals
Time frame: day 28
Re-intubation rate
Time frame: day 28
Lowest median SpO2 during intubation
for patients who were intubated during the study period
Time frame: days 1-3
Repartition of acute mild/moderate/severe respiratory distress syndrome (ARDS) stages after intubation or reintubation as defined by the Berlin definition
Time frame: day 28
Hypoxemic cardiac arrests
After discussion at the investigator meeting and based on comments from the Data and Safety Monitoring Board on May 12, 2016, all hypoxemic cardiac arrests will be considered as suspected unexpected serious adverse reaction
Time frame: day 28
Plan to share: Undecided
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris