Actively Recruiting
Closed Loop Oxygen Control in Intubated Critically Ill Patients - CLOC-IN
Led by Parc Taulí Hospital Universitari · Updated on 2025-02-17
46
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of closed-loop oxygen control compared to manual oxygen titration in critically ill patients who are intubated and mechanically ventilated due to hypoxemic acute respiratory failure. The study aims to see if automatic oxygen management can improve oxygen delivery by keeping patients within an optimal oxygen saturation range. This single-blind, randomized crossover clinical trial assesses the efficacy and safety of these two oxygen administration methods. Participants will be randomly assigned to receive either closed-loop oxygen control using the HAMILTON-C6 ventilator with O2 Assist software or manual oxygen titration by clinicians. Each treatment period lasts 4 hours, during which oxygen levels are adjusted either automatically based on continuous SpO2 measurements or manually according to preset target ranges. The crossover design means each patient experiences both methods in separate periods. Throughout the study, researchers will record clinical and respiratory data, including ventilator parameters like FiO2 and SpO2, using a memory box connected to the ventilator. The main outcome is the percentage of time spent within optimal and sub-optimal SpO2 ranges during each 4-hour period. Secondary measures include time spent outside target ranges, frequency of manual adjustments, oxygen usage, alarms, and oxygen saturation below critical thresholds. This helps evaluate which method better maintains safe oxygen levels in critically ill patients.
CONDITIONS
Brief Title
Closed Loop Oxygen Control in INtubated Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients admitted to the ICU expected to require invasive mechanical ventilation for at least 8 hours and remain respiratory stable for the next 8 hours
- Acute respiratory failure with PaO2/FiO2 less than 300 and FiO2 at least 0.4 at inclusion
- Age 18 years or older
- Written informed consent signed by the patient or a relative if the patient is unable to consent
You will not qualify if you...
- Low quality on SpO2 measurement using finger or ear sensor (quality index below 60%)
- Hemodynamic instability requiring continuous infusion of epinephrine or norepinephrine greater than 1 mg/h
- Severe acidosis with pH 7.30 or less
- Chronic or acute dyshemoglobinemia such as methemoglobin, carbon monoxide poisoning, or sickle cell disease
- Patient under guardianship or deprived of liberties
- Inability to give informed consent due to language barrier or lack of family consent
- Participation in another interventional research study with similar outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 hours total (two 4-hour periods)
Participants receive two 4-hour periods of oxygen management while mechanically ventilated. One period uses closed-loop oxygen control where oxygen is automatically adjusted based on measured oxygen saturation. The other period uses manual oxygen titration where oxygen is manually adjusted by clinicians. The order of these periods is randomized.
Single continuous session with monitoring during both periods
Trial Site Locations
Total: 1 location
1
Parc Tauli Hospital Universitary
Sabadell, Barcelona, Spain, 08028
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here