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

February 11, 2025 updated by: Oriol Roca, Parc Taulí Hospital Universitari

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08028
        • Recruiting
        • Parc Tauli Hospital Universitary
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. closed-loop oxygen control (CLOC)
Automatic Oxygen management sets the Oxygen control according to the patient's measured SpO2 and the operator-set SpO2 target range during 4h.
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.
Active Comparator: 2. manual oxygen titration (MOT)
Conventional oxygen manual management according to SpO2 target range set by clinician, during 4h.
Device: 2. manual oxygen titration (MOT)
O2 will be manually set according to SpO2 target during a 4h period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy outcome:
Time Frame: Hour 1 to 4
To compare the percentage of time spent in a predefined optimal SpO2 (oxygen saturation by pulse oximetry) range between closed-loop oxygen control and manual oxygen titration
Hour 1 to 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time with SpO2 (oxygen saturation by pulse oximetry) in sub-optimal ranges
Time Frame: Hour 1 to 4
To compare the percentage of time with SpO2 in sub-optimal ranges, above and below the optimal range, during closed-loop oxygen control and manual oxygen titration
Hour 1 to 4
Percentage of time with SpO2 (oxygen saturation by pulse oximetry) out of range
Time Frame: Hour 1 to 4
To compare the percentage of time with SpO2 out of range, above and below the optimal and sub-optimal range.
Hour 1 to 4
Number of manual adjustments
Time Frame: Hour 1 to 4
To compare the number of manual adjustments
Hour 1 to 4
Mean SpO2/FiO2 (oxygen saturation by pulse oximetry to fraction of inspired oxygen ratio) between the two methods
Time Frame: Hour 1 to 4
To compare the mean SpO2/FiO2 between the two methods of oxygen titration
Hour 1 to 4
Mean FiO2 (fraction of inspired oxygen) between the two methods of oxygen titration
Time Frame: Hour 1 to 4
To compare the mean FiO2 between the two methods of oxygen titration
Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) below 40%
Time Frame: Hour 1 to 4
To compare the percentage of time with FiO2 below 40%
Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) above 60%
Time Frame: Hour 1 to 4
To compare the percentage of time with FiO2 above 60%
Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) at 100%
Time Frame: Hour 1 to 4
To compare the percentage of time with FiO2 at 100%
Hour 1 to 4
SpO2 (oxygen saturation by pulse oximetry) below 88 and 85%.
Time Frame: Hour 1 to 4
To compare the percentage of time with SpO2 below 88 and 85%.
Hour 1 to 4
SpO2 (oxygen saturation by pulse oximetry) below 88 and 85% (Event > 10s and 60 s)
Time Frame: Hour 1 to 4
To compare the number of events with SpO2 below 88 and 85% (Event > 10s and 60 s)
Hour 1 to 4
Number of alarms
Time Frame: Hour 1 to 4
To compare the number of alarms
Hour 1 to 4
Time with SpO2 (oxygen saturation by pulse oximetry) signal available.
Time Frame: Hour 1 to 4
To compare the percentage of time with SpO2 signal available.
Hour 1 to 4
Total amount of oxygen used
Time Frame: Hour 1 to 4
To compare the total amount of oxygen used (in L)
Hour 1 to 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc Taulí Hospital Universitari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT_UCI_RESP1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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