In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decrease work of breathing as compared to standard oxygen therapy by facemask. Current guidelines recommend adjusting oxygen flow rates to keep the oxygen saturation measured by pulse oximetry (SpO2) in the target range and avoid hypoxemia and hyperoxemia. The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ICU patients treated with HFNT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
53
The Automatic FiO2 option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the Oxygen setting to keep the patient's SpO2 in the target range.
Manual FiO2 adjustment according to SpO2 values
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Percentage of time spent in optimal SpO2 range
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
Time frame: 4 hours
Percentage of time spent in sub-optimal SpO2 range
SpO2 values outside the optimal range but still within an acceptable limit (2-3 percent above and below the optimal range)
Time frame: 4 hours
Percentage of time spent out of range
Above or below the suboptimal limits specified at the begginning of the study
Time frame: 4 hours
Percentage of time with SpO2 signal available
Time with SpO2 signal available
Time frame: 4 hours
Mean SpO2/FiO2
Mean oxygenation value
Time frame: 4 hours
ROX index
Is a predictor of HFNT success/failure defined as (SpO2/FiO2)/respiratory rate
Time frame: 4 hours
Percentage of time with SpO2 below 88 and 85 percent
Duration of time with SpO2 \<85 percent and \<88 percent, respectively
Time frame: 4 hours
Number of events with SpO2 below 88 and 85 percent
Frequency of SpO2 decreases \<85 percent and \<88 percent, respectively
Time frame: 4 hours
Mean FiO2
Mean fraction of inspired oxygen
Time frame: 4 hours
Percentage of time with FiO2 below 40 percent and above 60%
Percentage of time that FiO2 is \<40 percent and \>60 percent, respectively
Time frame: 4 hours
Number of manual adjustments
Frequency of manual adjustments of FiO2
Time frame: 4 hours
Number of alarms
Frequency of alarms
Time frame: 4 hours
Patient comfort
Comfort score by visual analogic scale (from 0 to 10)
Time frame: 4 hours
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