NCT06829732 Closed Loop Oxygen Control in INtubated Critically Ill Patients
| NCT ID | NCT06829732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Parc Taulí Hospital Universitari |
| Condition | Hypoxemic Acute Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2023-04-01 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients admitted to the ICU who are expected to require invasive mechanical ventilation for at least 8 hours and are expected to stay respiratory stable´ in the upcoming 8 hours. * Acute respiratory failure with PaO2/FiO2 \<300 with FiO2 ≥ 0.4 at inclusion * Age older than 18 years old. * 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. Exclusion Criteria: * Low quality on the SpO2 measurement using finger and ear sensor (quality index \<60%). * Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h. * Severe acidosis (pH ≤ 7.30). * Chronic or acute dyshemoglobinemia: methemoglobin, CO poisoning, sickle cell disease. * Patient under guardianship or deprived of liberties. * Impossibility to give informed consent by both patient and family (i.e. language barrier). * Patient included in another interventional research study under consent with similar outcome.
Frequently Asked Questions
Who can join the NCT06829732 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypoxemic Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06829732 currently recruiting?
Yes, NCT06829732 is actively recruiting participants. Visit ClinicalTrials.gov or contact Parc Taulí Hospital Universitari to inquire about joining.
Where is the NCT06829732 trial being conducted?
This trial is being conducted at Sabadell, Spain.
Who is sponsoring the NCT06829732 clinical trial?
NCT06829732 is sponsored by Parc Taulí Hospital Universitari. The trial plans to enroll 46 participants.