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New treatment option for Acute Hypoxemic Respiratory Failure
Official title Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)
ClinicalTrials.gov ID: NCT06374589
What this study is testing
- What it's testing
- 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].
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Severe acidosis (pH ≤ 7.30)
- Pregnant woman
See the full eligibility 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Istanbul, Turkey (Türkiye)
- Izmir, Turkey (Türkiye)
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Istanbul, Turkey (Türkiye); Izmir, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.