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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygen close-loop | Experimental | Four hours period where the fraction of inspired oxygen delivered will be automatically titrated based on SpO2 values. |
|
| Manual FiO2 adjustment | Active Comparator | Four hours period where the fraction of inspired oxygen delivered will be manually adjusted by the healthcare personnel based on SpO2 values. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen close-loop | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time spent in optimal SpO2 range | The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 hours |
| Percentage of time spent out of range |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28729473 | Background | L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, Archambault P, Bouchard PA, Lellouche F. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017 Jul 20;50(1):1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul. | |
| 25855899 | Background | Helmerhorst HJ, Roos-Blom MJ, van Westerloo DJ, de Jonge E. Association Between Arterial Hyperoxia and Outcome in Subsets of Critical Illness: A Systematic Review, Meta-Analysis, and Meta-Regression of Cohort Studies. Crit Care Med. 2015 Jul;43(7):1508-19. doi: 10.1097/CCM.0000000000000998. |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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|
| No intervention | Device | Manual FiO2 adjustment according to SpO2 values |
|
Above or below the suboptimal limits specified at the begginning of the study
| 4 hours |
| Percentage of time with SpO2 signal available | Time with SpO2 signal available | 4 hours |
| Mean SpO2/FiO2 | Mean oxygenation value | 4 hours |
| ROX index | Is a predictor of HFNT success/failure defined as (SpO2/FiO2)/respiratory rate | 4 hours |
| Percentage of time with SpO2 below 88 and 85 percent | Duration of time with SpO2 <85 percent and <88 percent, respectively | 4 hours |
| Number of events with SpO2 below 88 and 85 percent | Frequency of SpO2 decreases <85 percent and <88 percent, respectively | 4 hours |
| Mean FiO2 | Mean fraction of inspired oxygen | 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 | 4 hours |
| Number of manual adjustments | Frequency of manual adjustments of FiO2 | 4 hours |
| Number of alarms | Frequency of alarms | 4 hours |
| Patient comfort | Comfort score by visual analogic scale (from 0 to 10) | 4 hours |
| 28679200 | Background | Arnal JM, Garnero A, Novotni D, Corno G, Donati SY, Demory D, Quintana G, Ducros L, Laubscher T, Durand-Gasselin J. Closed loop ventilation mode in Intensive Care Unit: a randomized controlled clinical trial comparing the numbers of manual ventilator setting changes. Minerva Anestesiol. 2018 Jan;84(1):58-67. doi: 10.23736/S0375-9393.17.11963-2. Epub 2017 Jul 5. |
| 35422002 | Derived | Roca O, Caritg O, Santafe M, Ramos FJ, Pacheco A, Garcia-de-Acilu M, Ferrer R, Schultz MJ, Ricard JD. Closed-loop oxygen control improves oxygen therapy in acute hypoxemic respiratory failure patients under high flow nasal oxygen: a randomized cross-over study (the HILOOP study). Crit Care. 2022 Apr 14;26(1):108. doi: 10.1186/s13054-022-03970-w. |
| D012140 | Respiratory Tract Diseases |