An interventional study of closed-loop oxygen control (CLOC) and 2. manual oxygen titration (MOT) in Hypoxemic Acute Respiratory Failure, sponsored by Parc Taulí Hospital Universitari. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Parc Taulí Hospital Universitari · Not applicable, Interventional, and Supportive care
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.
The deleterious effects of alveolar hyperoxia and (severe) hyperoxaemia are well described. A safe and efficient oxygenation should be achieved. However, from a practical point of view, this may require frequent manual adjustments of the inspired oxygen, which might be unfeasible, especially in high-demand periods. Several automatic oxygen systems have been tested in non-intubated patients. 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. Thus, the objective of the study is to compare the percentage of time spent in a predefined optimal SpO2 range between closed-loop oxygen control and manual oxygen titration.
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. Once included, patients will be randomised to receive first either closed-loop oxygen control (CLOC) or manual oxygen titration (MOT). Every period will last for 4h. Clinical and respiratory variables will be recorded. A memory box will be connected to the patient's ventilator. This device will record ventilator parameters, including FiO2 and SpO2. To assess the outcome, the percentage of time spent in optimal and sub-optimal SpO2 ranges will be calculated for each period.
1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.
This study's planned enrollment of 46 is below the median of 55 across 1,056 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Parc Taulí Hospital Universitari is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Automatic Oxygen management sets the Oxygen control according to the patient's measured SpO2 and the operator-set SpO2 target range during 4h.
Device: closed-loop oxygen control (CLOC)
Conventional oxygen manual management according to SpO2 target range set by clinician, during 4h.
Device: 2. manual oxygen titration (MOT)
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.
O2 will be manually set according to SpO2 target during a 4h period.
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 4
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 4
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 4
Number of manual adjustments
To compare the number of manual adjustments
Time frame: Hour 1 to 4
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 4
Mean FiO2 (fraction of inspired oxygen) between the two methods of oxygen titration
To compare the mean FiO2 between the two methods of oxygen titration
Time frame: Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) below 40%
To compare the percentage of time with FiO2 below 40%
Time frame: Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) above 60%
To compare the percentage of time with FiO2 above 60%
Time frame: Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) at 100%
To compare the percentage of time with FiO2 at 100%
Time frame: Hour 1 to 4
SpO2 (oxygen saturation by pulse oximetry) below 88 and 85%.
To compare the percentage of time with SpO2 below 88 and 85%.
Time frame: Hour 1 to 4
SpO2 (oxygen saturation by pulse oximetry) below 88 and 85% (Event > 10s and 60 s)
To compare the number of events with SpO2 below 88 and 85% (Event \> 10s and 60 s)
Time frame: Hour 1 to 4
Number of alarms
To compare the number of alarms
Time frame: Hour 1 to 4
Time with SpO2 (oxygen saturation by pulse oximetry) signal available.
To compare the percentage of time with SpO2 signal available.
Time frame: Hour 1 to 4
Total amount of oxygen used
To compare the total amount of oxygen used (in L)
Time frame: Hour 1 to 4
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Parc Taulí Hospital Universitari