RecruitingNot ApplicableNCT06829732

Closed Loop Oxygen Control in INtubated Critically Ill Patients

Closed Loop Oxygen Control in INtubated Critically Ill Patients - CLOC-IN


Sponsor

Parc Taulí Hospital Universitari

Enrollment

46 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called 2. manual oxygen titration (MOT) and a medical device called closed-loop oxygen control (CLOC) for people with hypoxemic acute respiratory failure. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEclosed-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.

DEVICE2. manual oxygen titration (MOT)

O2 will be manually set according to SpO2 target during a 4h period.


Locations(1)

Parc Tauli Hospital Universitary

Sabadell, Barcelona, Spain

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NCT06829732


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