Closed Loop Oxygen Control in INtubated Critically Ill Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 2. manual oxygen titration (MOT)
  O2 will be manually set according to SpO2 target during a 4h period.

Первичные конечные точки

• Efficacy outcome: [Срок оценки: Hour 1 to 4]

Вторичные конечные точки (12)

• Percentage of time with SpO2 (oxygen saturation by pulse oximetry) in sub-optimal ranges [Срок оценки: Hour 1 to 4]
• Percentage of time with SpO2 (oxygen saturation by pulse oximetry) out of range [Срок оценки: Hour 1 to 4]
• Number of manual adjustments [Срок оценки: Hour 1 to 4]
• Mean SpO2/FiO2 (oxygen saturation by pulse oximetry to fraction of inspired oxygen ratio) between the two methods [Срок оценки: Hour 1 to 4]
• Mean FiO2 (fraction of inspired oxygen) between the two methods of oxygen titration [Срок оценки: Hour 1 to 4]
• Time with FiO2 (fraction of inspired oxygen) below 40% [Срок оценки: Hour 1 to 4]
• Time with FiO2 (fraction of inspired oxygen) above 60% [Срок оценки: Hour 1 to 4]
• Time with FiO2 (fraction of inspired oxygen) at 100% [Срок оценки: Hour 1 to 4]
• SpO2 (oxygen saturation by pulse oximetry) below 88 and 85%. [Срок оценки: Hour 1 to 4]
• SpO2 (oxygen saturation by pulse oximetry) below 88 and 85% (Event > 10s and 60 s) [Срок оценки: Hour 1 to 4]
• Number of alarms [Срок оценки: Hour 1 to 4]
• Time with SpO2 (oxygen saturation by pulse oximetry) signal available. [Срок оценки: Hour 1 to 4]

Критерии участия

Критерии включения

• Patients admitted to the ICU who are expected to require invasive mechanical ventilation for at least 8 hours and are expected to stay respiratory stable´ in the upcoming 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 case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation.

Критерии исключения

• 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 or norepinephrine > 1 mg/h.
• Severe acidosis (pH ≤ 7.30).
• Chronic or acute dyshemoglobinemia: methemoglobin, CO poisoning, sickle cell disease.
• Patient under guardianship or deprived of liberties.
• Impossibility to give informed consent by both patient and family (i.e. language barrier).
• Patient included in another interventional research study under consent with similar outcome.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 1 центр

• Parc Tauli Hospital Universitary — Sabadell

Идентификаторы

NCT: NCT06829732 · PT_UCI_RESP1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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