Hypoxemic Acute Respiratory FailureCLOC-INNCT06829732
Closed Loop Oxygen Control in INtubated Critically Ill Patients
A study testing 2. manual oxygen titration (MOT) in people with Hypoxemic Acute Respiratory Failure, run by Parc Taulí Hospital Universitari at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemic Acute Respiratory Failure
- What is being tested?
- 2. manual oxygen titration (MOT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Parc Tauli Hospital Universitary
Sabadell, Barcelona, 08028
Marina García-de-Acilu, PhD, +34661739188, mggacilu@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypoxemic Acute Respiratory Failure
- Being tested
- closed-loop oxygen control (CLOC), 2. manual oxygen titration (MOT)
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed-loop oxygen control (CLOC)Device
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.
2. manual oxygen titration (MOT)Device
O2 will be manually set according to SpO2 target during a 4h period.
| Study group | Role | What they receive |
|---|---|---|
| 1. closed-loop oxygen control (CLOC) | Experimental | Automatic Oxygen management sets the Oxygen control according to the patient's measured SpO2 and the operator-set SpO2 target range during 4h. Receives: Device: closed-loop oxygen control (CLOC) |
| 2. manual oxygen titration (MOT) | Active comparator | Conventional oxygen manual management according to SpO2 target range set by clinician, during 4h. Receives: Device: 2. manual oxygen titration (MOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy outcome:
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
Measured: Hour 1 to 4
Secondary outcomes (13)
Percentage of time with SpO2 (oxygen saturation by pulse oximetry) in sub-optimal ranges
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
Measured: Hour 1 to 4
Percentage of time with SpO2 (oxygen saturation by pulse oximetry) out of range
To compare the percentage of time with SpO2 out of range, above and below the optimal and sub-optimal range.
Measured: Hour 1 to 4
Number of manual adjustments
To compare the number of manual adjustments
Measured: Hour 1 to 4
Mean SpO2/FiO2 (oxygen saturation by pulse oximetry to fraction of inspired oxygen ratio) between the two methods
To compare the mean SpO2/FiO2 between the two methods of oxygen titration
Measured: Hour 1 to 4
Mean FiO2 (fraction of inspired oxygen) between the two methods of oxygen titration
To compare the mean FiO2 between the two methods of oxygen titration
Measured: Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) below 40%
To compare the percentage of time with FiO2 below 40%
Measured: Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) above 60%
To compare the percentage of time with FiO2 above 60%
Measured: Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) at 100%
To compare the percentage of time with FiO2 at 100%
Measured: Hour 1 to 4
SpO2 (oxygen saturation by pulse oximetry) below 88 and 85%.
To compare the percentage of time with SpO2 below 88 and 85%.
Measured: Hour 1 to 4
SpO2 (oxygen saturation by pulse oximetry) below 88 and 85% (Event > 10s and 60 s)
To compare the number of events with SpO2 below 88 and 85% (Event > 10s and 60 s)
Measured: Hour 1 to 4
Number of alarms
To compare the number of alarms
Measured: Hour 1 to 4
Time with SpO2 (oxygen saturation by pulse oximetry) signal available.
To compare the percentage of time with SpO2 signal available.
Measured: Hour 1 to 4
Total amount of oxygen used
To compare the total amount of oxygen used (in L)
Measured: Hour 1 to 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Apr 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemic Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Every patient included will be randomize to recieved both arm in different order. Every period will last for 4 h.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc Taulí Hospital Universitari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oriol Roca, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829732
- Sponsor's protocol ID
- PT_UCI_RESP1
- Acronym
- CLOC-IN
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Loop Oxygen Control in INtubated Critically Ill Patients - CLOC-IN
- ClinicalTrials.gov ID
- NCT06829732
- Acronym / sponsor ID
- CLOC-IN / PT_UCI_RESP1
- Conditions
- Hypoxemic Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Every patient included will be randomize to recieved both arm in different order. Every period will last for 4 h.
| Arm | Type | Receives |
|---|---|---|
| 1. closed-loop oxygen control (CLOC) | Experimental | Device: 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. |
| 2. manual oxygen titration (MOT) | Active comparator | Device: 2. manual oxygen titration (MOT)Conventional oxygen manual management according to SpO2 target range set by clinician, during 4h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 1. closed-loop oxygen control (CLOC) |
| 2. manual oxygen titration (MOT)O2 will be manually set according to SpO2 target during a 4h period. | Device | 2. manual oxygen titration (MOT) |
Primary outcome
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
13 secondary outcomes
Percentage of time with SpO2 (oxygen saturation by pulse oximetry) in sub-optimal ranges
Time frame: Hour 1 to 4
Percentage of time with SpO2 (oxygen saturation by pulse oximetry) out of range
Time frame: Hour 1 to 4
Number of manual adjustments
Time frame: 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
Mean FiO2 (fraction of inspired oxygen) between the two methods of oxygen titration
Time frame: Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) below 40%
Time frame: Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) above 60%
Time frame: Hour 1 to 4
Time with FiO2 (fraction of inspired oxygen) at 100%
Time frame: Hour 1 to 4
SpO2 (oxygen saturation by pulse oximetry) below 88 and 85%.
Time frame: 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
Number of alarms
Time frame: Hour 1 to 4
Time with SpO2 (oxygen saturation by pulse oximetry) signal available.
Time frame: Hour 1 to 4
Total amount of oxygen used
Time frame: Hour 1 to 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2. manual oxygen titration (MOT) in people with Hypoxemic Acute Respiratory Failure, run by Parc Taulí Hospital Universitari at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy outcome: (time frame: Hour 1 to 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.