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Closed Loop Oxygen Control in INtubated Critically Ill Patients

NCT06829732 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-02-17

No results posted yet for this study

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.

Conditions

  • Hypoxemic Acute Respiratory Failure

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.

Sponsors & Collaborators

  • Parc Taulí Hospital Universitari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06829732 on ClinicalTrials.gov