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Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)

RecruitingNAAges 18 Years - anyAllBaşakşehir Çam & Sakura City Hospital
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In plain words

What the trial is, and whether it could suit you

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 controll

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Patient admitted to the ER * Requiring NHFO * Requiring FiO2 ≥ 30% to keep SpO2 in the target ranges defined by the clinician * Aged over 18 years * Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation * In case that the consent is given by the relative, patient consent will be requested as soon as the patient will be able to provide informed written consent Exclusion Criteria: Patients who fulfil any of the following exclusion criteria are not eligible for study participation: * Patient with indication for immediate CPAP, NIV, or invasive mechanical ventilation * Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h * Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the Massimo SpO2 sensor, which is displayed by a red or orange color bar) * Severe acidosis (pH ≤ 7.30) * Pregnant woman * Patients deemed at high risk for need of mechanical ventilation within the next 12 hours * Chronic or acute dyshemoglobinemia: methemoglobin, CO poisoning, sickle cell disease * Tracheotomized patient * Formalized ethical decision to withhold or withdraw life support * Patient under guardianship * Patient deprived of liberties * Patient included in another interventional research study under consent * Patient already enrolled in the present study in a previous episode of acute respiratory failure Post enrollment exclusion criteria * Apparition of a persistent low quality SpO2 signal * Need for an emergent intubation * Discharge from ER
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What it tests

  • Closed-loop FiO2 controller
  • Conventional
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Where

2 sites
Başakşehir Çam & Sakura City Hospital
Istanbul, Turkey (Türkiye)
Dr.Suat Seren Chest Diseasees Hospital
Izmir, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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