Closed Loop Oxygen Control in INtubated Critically Ill Patients
ConditionHypoxemic Acute Respiratory Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorParc Taulí Hospital Universitari
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- closed-loop oxygen control (CLOC)
- 2. manual oxygen titration (MOT)
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
Parc Taulí Hospital Universitari
Lead sponsor
Corporacion Parc Tauli
Sponsor institution
Source ClinicalTrials.gov