Using a closed-loop oxygen controller for high flow oxygen treatment in critically ill adults
Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)- a Randomized Cross-over Study
This study is testing a new system that automatically adjusts oxygen levels for critically ill adults with breathing problems to see if it helps them breathe better than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Başakşehir Çam & Sakura City Hospital Government |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Trial ID | NCT06374589 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are admitted to the emergency room and require high flow nasal oxygen therapy with an FiO2 of 30% or more.
Not a fit: Patients who need immediate CPAP, NIV, or invasive mechanical ventilation, or those with hemodynamic instability, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise oxygen delivery, reducing the risks associated with hyperoxia and improving recovery in critically ill patients.
How similar studies have performed: While the use of closed-loop systems in oxygen therapy is a novel approach, similar studies have shown promise in improving oxygen management in critical care settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Istanbul and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.