Improving oxygen delivery in critically ill patients on ventilators
Closed Loop Oxygen Control in INtubated Critically Ill Patients - CLOC-IN
This study is testing if a new automatic system for controlling oxygen can help critically ill patients on ventilators keep their oxygen levels stable better than the usual manual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Parc Taulí Hospital Universitari Academic / other |
| Locations | 1 site (Sabadell, Barcelona) |
| Trial ID | NCT06829732 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of closed-loop oxygen control compared to manual oxygen titration in intubated patients with acute respiratory failure. It is designed as a single-blind, randomized crossover trial where patients will receive both interventions in alternating periods. The study aims to measure the percentage of time patients maintain optimal oxygen saturation levels while receiving mechanical ventilation. Data will be collected on various clinical and respiratory parameters to assess the safety and efficacy of the closed-loop system.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are admitted to the ICU and expected to need invasive mechanical ventilation for at least 8 hours due to acute respiratory failure.
Not a fit: Patients with severe acidosis, hemodynamic instability, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better oxygen management and improved outcomes for critically ill patients requiring mechanical ventilation.
How similar studies have performed: While automatic oxygen systems have been tested in non-intubated patients, this specific approach in intubated critically ill patients is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sabadell, Barcelona
- Parc Tauli Hospital Universitary — Sabadell, Barcelona, Spain (Recruiting)
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.