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| Name | Class |
|---|---|
| Hamilton Medical AG | INDUSTRY |
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High flow nasal oxygen therapy (HFNO) is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure. The high humidified gas flow supports patient's work of breathing, reduces dead space ventilation, and improves functional residual capacity while using an unobtrusive patient's face interface [Mauri et al, 2017; Möller et al, 2017].
As hyperoxia is considered not desirable [Barbateskovic et al, 2019] during any oxygen therapy, the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96% in patients without hypercapnia risk, and of 88-92% if a risk of hypercapnia is present [O'Driscoll et al, 2017; Beasley et al, 2015]. In most institutions, the standard of care is to manually adapt the FiO2, although patients frequently have a SpO2 value outside the target range.
A new closed loop oxygen controller designed for HFNO was recently developed (Hamilton Medical, Bonaduz, Switzerland). The clinician sets SpO2 targets, and the software option adjusts FiO2 to keep SpO2 within the target ranges. The software option offers some alarms on low and high SpO2 and high FiO2. Given the capability, on the one hand, to quickly increase FiO2 in patients developing sudden and profound hypoxia, and, on the other hand, of automatically preventing hyperoxia in patients improving their oxygenation, such a system could be particularly useful in patients treated with HFNO.
A short-term (4 hours vs 4 hours) crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy [Roca et al, 2022]. Due to its simplicity, HFNO is increasingly used outside the ICU during transport and in the Emergency Room (ER). This environment poses specific challenges, as patients may deteriorate very quickly and depending on patient's flow, healthcare providers can easily be overwhelmed. We thus propose to evaluate closed loop controlled HFNO in ER patients.
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 ER patients treated with HFNO.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Close-loop FiO2 Controller | Experimental | Six hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient. |
|
| Conventional | Active Comparator | Six hours period where the fraction of inspired oxygen (FiO2) delivered will be manually titrated by clinician based on SpO2 values obtained from the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-loop FiO2 controller | Device | Close-loop FiO2 controller software 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 FiO2 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. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time with SpO2 signal available | Time with SpO2 signal available | 6 hours |
| Percentage of time with SpO2 below target range | SpO2 values below the optimal range |
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Inclusion Criteria:
Exclusion Criteria:
Patients who fulfil any of the following exclusion criteria are not eligible for study participation:
Post enrollment exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramazan Guven, Associate prof | Contact | 05354935995 | drramazanguven@gmail.com | |
| Mustafa Colak, MD | Contact | colakk@hotmail.com.tr |
| Name | Affiliation | Role |
|---|---|---|
| Ramazan Guven, Associate prof | Basaksehir Cam Sakura city Hospital, Istanbul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başakşehir Çam & Sakura City Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36465920 | Background | Sandal O, Ceylan G, Topal S, Hepduman P, Colak M, Novotni D, Soydan E, Karaarslan U, Atakul G, Schultz MJ, Agin H. Closed-loop oxygen control improves oxygenation in pediatric patients under high-flow nasal oxygen-A randomized crossover study. Front Med (Lausanne). 2022 Nov 16;9:1046902. doi: 10.3389/fmed.2022.1046902. eCollection 2022. | |
| 35422002 |
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|
| Conventional | Device | Six hours period where the fraction of inspired oxygen (FiO2) delivered will be manually titrated by clinician based on SpO2 values obtained from the patient. |
|
| 6 hours |
| Percentage of time with SpO2 above target range | SpO2 values above the optimal range | 6 hours |
| Percentage of time with SpO2 outside optimal range | SpO2 values outside the optimal range | 6 hours |
| Percentage of time with with FiO2 below 40% | Duration of time with FiO2 < 40 % | 6 hours |
| Percentage of time with with FiO2 above 60% | Duration of time with FiO2 > 60 % | 6 hours |
| Percentage of time with with FiO2 = 100% | Duration of time with FiO2 = 60 % | 6 hours |
| Mean SpO2/FiO2 | Mean SpO2/FiO2 | 6 hours |
| Number of events with SpO2 below of target range (duration >10 s) | Frequency of events with SpO2 below of target range (duration >10 s) | 6 hours |
| Number of events with SpO2 below of target range (duration >60 s) | Frequency of events with SpO2 below of target range (duration >60 s) | 6 hours |
| Number of events with SpO2 below the predefined low SpO2 emergency limit | Frequency of events with SpO2 below of the predefined low SpO2 emergency limit | 6 hours |
| Number of events with SpO2 above the predefined low SpO2 emergency limit | Frequency of events with SpO2 above of the predefined low SpO2 emergency limit | 6 hours |
| Total oxygen use | Amount of additional oxygen use | 6 hours |
| Dr.Suat Seren Chest Diseasees Hospital | Recruiting | Izmir | 35230 | Turkey (Türkiye) |
|
| 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. |
| 36481622 | Background | Dijkman KP, Goos TG, Dieleman JP, Mohns T, van Pul C, Andriessen P, Kroon AA, Reiss IK, Niemarkt HJ. Predictive Intelligent Control of Oxygenation in Preterm Infants: A Two-Center Feasibility Study. Neonatology. 2023;120(2):235-241. doi: 10.1159/000527539. Epub 2022 Dec 8. |
| 38423953 | Background | O'Driscoll BR, Kirton L, Weatherall M, Bakerly ND, Turkington P, Cook J, Beasley R. Effect of a lower target oxygen saturation range on the risk of hypoxaemia and elevated NEWS2 scores at a university hospital: a retrospective study. BMJ Open Respir Res. 2024 Feb 29;11(1):e002019. doi: 10.1136/bmjresp-2023-002019. |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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