Closed Loop Oxygen Control in INtubated Critically Ill Patients

NCT06829732 · tracked via the Priya Life Science Spain tracker

Sponsor

Parc Taulí Hospital Universitari

Phase

Not applicable

Started

2023-04-01

Last updated

2025-02-17

Condition(s) studied

Hypoxemic Acute Respiratory Failure

Investigational drug(s) / intervention(s)

closed-loop oxygen control (CLOC)2. manual oxygen titration (MOT)

closed-loop oxygen control (CLOC): HAMILTON-C6 (Hamilton Medical, Bonaduz, Switzerland) ventilators will be used. It allows for O2 Assist software, that will be installed on all C6 ventilators before the start of this study. Automatic Oxygen management sets the Oxygen control according to the patient's measured SpO2 and the operator-set SpO2 target range. The Oxygenation controller will be activated for 4h and adjusts the Oxygen according to patient's measured SpO2.

2. manual oxygen titration (MOT): O2 will be manually set according to SpO2 target during a 4h period.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Efficacy outcome: — Hour 1 to 4
To compare the percentage of time spent in a predefined optimal SpO2 (oxygen saturation by pulse oximetry) range between closed-loop oxygen control and manual oxygen titration

Trial sites (1)

Facility	City	Region	Status
Parc Tauli Hospital Universitary	Sabadell	Barcelona	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06829732 on ClinicalTrials.gov ↗ ← All trials in Spain