Actively Recruiting
Closed Loop Oxygen Control in INtubated Critically Ill Patients
Led by Parc Taulí Hospital Universitari · Updated on 2025-02-17
46
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The deleterious effects of alveolar hyperoxia and (severe) hyperoxaemia are well described. Achieving safe and efficient oxygenation may be challenging. The hypothesis of the present study is that closed-loop oxygen control in intubated and mechanically ventilated critically ill patients improves oxygen administration compared with standard manual oxygen titrations. A single-blind, randomised crossover clinical trial assessing the efficacy and safety of the use of a closed-loop oxygen control versus manual oxygen titration in patients receiving mechanical ventilation has been designed. Patients will be randomised to receive first either closed-loop oxygen control (CLOC) or manual oxygen titration (MOT). The percentage of time spent in optimal and sub-optimal SpO2 (oxygen saturation by pulse oximetry) ranges will be calculated for each period.
CONDITIONS
Official 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 who are 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 ratio less than 300 and FiO2 at or above 0.4 at inclusion
- Age older than 18 years
- Written informed consent signed by the patient or a relative if the patient cannot consent, after full study explanation
You will not qualify if you...
- Low quality SpO2 measurement using finger and ear sensors (quality index below 60%)
- Hemodynamic instability requiring continuous infusion of epinephrine or norepinephrine greater than 1 mg/h
- Severe acidosis with pH less than or equal to 7.30
- 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 by patient and family (e.g., language barrier)
- Participation in another interventional research study with a similar outcome
AI-Screening
AI-Powered Screening
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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
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