Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
NCT Number: NCT04965844
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08035, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 4 hours
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
Time frame: 4 hours
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
Above or below the suboptimal limits specified at the begginning of the study
Time frame: 4 hours
Time with SpO2 signal available
Time frame: 4 hours
Mean oxygenation value
Time frame: 4 hours
Is a predictor of HFNT success/failure defined as (SpO2/FiO2)/respiratory rate
Time frame: 4 hours
Duration of time with SpO2 <85 percent and <88 percent, respectively
Time frame: 4 hours
Frequency of SpO2 decreases <85 percent and <88 percent, respectively
Time frame: 4 hours
Mean fraction of inspired oxygen
Time frame: 4 hours
Percentage of time that FiO2 is <40 percent and >60 percent, respectively
Time frame: 4 hours
Frequency of manual adjustments of FiO2
Time frame: 4 hours
Frequency of alarms
Time frame: 4 hours
Comfort score by visual analogic scale (from 0 to 10)
Hospital Universitari Vall d'Hebron Research Institute
Other
Safety and Efficacy of a Closed-loop Oxygen Control for High Flow Nasal Therapy in ICU Patients: a Randomized Cross-over Study (The HILOOP Study)
Acronym: HILOOP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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