Closed-loop oxygen control improves oxygenation in pediatric patients under high-flow nasal oxygen-A randomized crossover study.
Ozlem Sandal, Gokhan Ceylan, Sevgi Topal...
https://pubmed.ncbi.nlm.nih.gov/36465920Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06374589
Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT) - a Randomized Cross-over Study
Led by Başakşehir Çam & Sakura City Hospital · Updated on 2025-01-28
50
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
B
Başakşehir Çam & Sakura City Hospital
Lead Sponsor
H
Hamilton Medical AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new oxygen delivery method called closed-loop oxygen control during high flow nasal oxygen therapy (HFNO) for adults with acute respiratory failure in emergency room settings. HFNO supports breathing by delivering humidified oxygen through a nasal interface, but current oxygen levels are manually adjusted, often leading to oxygen saturation levels outside the desired range. The study aims to see if automated oxygen control improves time spent within the target oxygen saturation range compared to manual adjustment. The trial compares two 6-hour periods of oxygen delivery in a randomized crossover design. In one period, oxygen levels (FiO2) are automatically adjusted by a closed-loop controller based on continuous oxygen saturation (SpO2) monitoring, maintaining target SpO2 levels set by clinicians. In the other period, oxygen is manually adjusted by clinicians based on SpO2 readings. This device-based approach is designed to quickly respond to changes in oxygen needs and avoid excessive oxygen exposure. Participants admitted to the emergency room who require HFNO with FiO2 of at least 30% will be involved. Researchers will monitor oxygen saturation continuously and record the percentage of time spent within the optimal SpO2 range over 6 hours. Secondary measures include time with SpO2 below or above target ranges, oxygen usage, and event counts of oxygen desaturation. Safety monitoring includes quality of SpO2 signals and clinical status. The study will assess whether automated control can improve oxygen management during critical care treatment.
CONDITIONS
Brief Title
Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient admitted to the emergency room
- Requires nasal high flow oxygen (NHFO)
- Requires fraction of inspired oxygen (FiO2) of at least 30% to maintain target oxygen saturation
- Aged over 18 years
- Able to provide written informed consent, or a relative can consent if patient is unable
- Patient consent will be requested as soon as able if initially given by relative
You will not qualify if you...
- Requires immediate CPAP, non-invasive ventilation, or invasive mechanical ventilation
- Hemodynamic instability needing continuous epinephrine or norepinephrine infusion over 1 mg/h
- Low quality oxygen saturation measurement signal (quality index below 60%)
- Severe acidosis with blood pH of 7.30 or lower
- Pregnant women
- High risk for mechanical ventilation within 12 hours
- Chronic or acute blood disorders affecting oxygen carrying (methemoglobin, CO poisoning, sickle cell disease)
- Tracheotomized patients
- Ethical decision to withhold or withdraw life support
- Under guardianship or deprived of liberties
- Currently enrolled in another interventional study
- Previously enrolled in this study for a prior acute respiratory failure episode
- After enrollment, if poor SpO2 signal quality persists
- Need for emergency intubation
- Discharge from emergency room
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Two 6-hour treatment periods
Participants receive two 6-hour periods of oxygen therapy using different devices to maintain target oxygen saturation. One period uses a closed-loop FiO2 controller that automatically adjusts oxygen levels, and the other uses conventional manual titration by clinicians.
2 treatment sessions of 6 hours each
Trial Site Locations
Total: 2 locations
1
Başakşehir Çam & Sakura City Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
2
Dr.Suat Seren Chest Diseasees Hospital
Izmir, Turkey (Türkiye), 35230
Actively Recruiting
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Research Team
R
Ramazan Guven, Associate prof
M
Mustafa Colak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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).
Oriol Roca, Oriol Caritg, Manel Santafé...
https://pubmed.ncbi.nlm.nih.gov/35422002Predictive Intelligent Control of Oxygenation in Preterm Infants: A Two-Center Feasibility Study.
Koen P Dijkman, Tom G Goos, Jeanne P Dieleman...
https://pubmed.ncbi.nlm.nih.gov/36481622Effect of a lower target oxygen saturation range on the risk of hypoxaemia and elevated NEWS2 scores at a university hospital: a retrospective study.
B Ronan O'Driscoll, Louis Kirton, Mark Weatherall...
https://pubmed.ncbi.nlm.nih.gov/38423953