Closed Loop Oxygen Control in INtubated Critically Ill Patients

Last updated: February 11, 2025
Sponsor: Parc Taulí Hospital Universitari
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

2. manual oxygen titration (MOT)

closed-loop oxygen control (CLOC)

Clinical Study ID

NCT06829732
PT_UCI_RESP1
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients admitted to the ICU who are expected to require invasive mechanicalventilation for at least 8 hours and are expected to stay respiratory stable´ in theupcoming 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 casethat the patient is unable to consent, after full explanation of the study by theinvestigator and prior to study participation.

Exclusion

Exclusion Criteria:

  • 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 ornorepinephrine > 1 mg/h.

  • Severe acidosis (pH ≤ 7.30).

  • Chronic or acute dyshemoglobinemia: methemoglobin, CO poisoning, sickle celldisease.

  • Patient under guardianship or deprived of liberties.

  • Impossibility to give informed consent by both patient and family (i.e. languagebarrier).

  • Patient included in another interventional research study under consent with similaroutcome.

Study Design

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: 2. manual oxygen titration (MOT)
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
March 31, 2025

Study Description

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.

Connect with a study center

  • Parc Tauli Hospital Universitary

    Sabadell, Barcelona 08028
    Spain

    Active - Recruiting

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