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RECRUITING
NCT06829732
NA

Closed Loop Oxygen Control in INtubated Critically Ill Patients

Sponsor: Parc Taulí Hospital Universitari

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2023-04-01

Completion Date

2025-03

Last Updated

2025-02-17

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

2. 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