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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
closed-loop oxygen control (CLOC)
DeviceHAMILTON-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)
DeviceO2 will be manually set according to SpO2 target during a 4h period.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: 1. closed-loop oxygen control (CLOC)Experimental treatment 1 intervention
Group B: 2. manual oxygen titration (MOT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy outcome:
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
Time frame
Hour 1 to 4Secondary outcomes
1
Percentage of time with SpO2 (oxygen saturation by pulse oximetry) in sub-optimal ranges
To compare the percentage of time with SpO2 in sub-optimal ranges, above and below the optimal range, during closed-loop oxygen control and manual oxygen titration
Time frame
Hour 1 to 42
Percentage of time with SpO2 (oxygen saturation by pulse oximetry) out of range
To compare the percentage of time with SpO2 out of range, above and below the optimal and sub-optimal range.
Time frame
Hour 1 to 43
Number of manual adjustments
To compare the number of manual adjustments
Time frame
Hour 1 to 44
Mean SpO2/FiO2 (oxygen saturation by pulse oximetry to fraction of inspired oxygen ratio) between the two methods
To compare the mean SpO2/FiO2 between the two methods of oxygen titration
Time frame
Hour 1 to 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Parc Taulí Hospital Universitari
Lead sponsor
Corporacion Parc Tauli
Sponsor institution
Source ClinicalTrials.gov