Using a closed-loop oxygen controller for high flow oxygen treatment in critically ill adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a closed-loop oxygen controller designed for high flow nasal oxygen therapy (HFNO) in adult patients experiencing acute respiratory failure. The intervention aims to automatically adjust the fraction of inspired oxygen (FiO2) to maintain target oxygen saturation levels, potentially improving patient outcomes compared to conventional manual adjustments. Patients will be monitored for their oxygen saturation levels, and the closed-loop system will adapt the oxygen delivery accordingly. The study is conducted in emergency settings where patients require high flow oxygen therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Başakşehir Çam & Sakura City Hospital
  Istanbul, Turkey (Türkiye) Recruiting
• Dr.Suat Seren Chest Diseasees Hospital
  Izmir, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Ramazan Guven, Associate prof — Basaksehir Cam Sakura city Hospital, Istanbul
• Study coordinator: Ramazan Guven, Associate prof
• Email: drramazanguven@gmail.com
• Phone: 05354935995

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.