Acute Hypoxemic Respiratory FailureCLOUDHFOTNCT06374589
Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)
A study testing Conventional in people with Acute Hypoxemic Respiratory Failure and Acute Hypercapnic Respiratory Failure, run by Başakşehir Çam & Sakura City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
High flow nasal oxygen therapy (HFNO) is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure. The high humidified gas flow supports patient's work of breathing, reduces dead space ventilation, and improves functional residual capacity while using an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure, Respiratory Depression
- What is being tested?
- Conventional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 21 Mar 2024to 30 May 2026
- 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
- Patient admitted to the ER
- Requiring NHFO
- Requiring FiO2 ≥ 30% to keep SpO2 in the target ranges defined by the clinician
- Aged over 18 years
- 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
- In case that the consent is given by the relative, patient consent will be requested as soon as the patient will be able to provide informed written consent
Who cannot join
- Patients who fulfil any of the following exclusion criteria are not eligible for study participation:
- Patient with indication for immediate CPAP, NIV, or invasive mechanical ventilation
- Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
- Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the Massimo SpO2 sensor, which is displayed by a red or orange color bar)
- Severe acidosis (pH ≤ 7.30)
- Pregnant woman
Show all 18Show fewer
- Patients deemed at high risk for need of mechanical ventilation within the next 12 hours
- Chronic or acute dyshemoglobinemia: methemoglobin, CO poisoning, sickle cell disease
- Tracheotomized patient
- Formalized ethical decision to withhold or withdraw life support
- Patient under guardianship
- Patient deprived of liberties
- Patient included in another interventional research study under consent
- Patient already enrolled in the present study in a previous episode of acute respiratory failure
- Post enrollment exclusion criteria
- Apparition of a persistent low quality SpO2 signal
- Need for an emergent intubation
- Discharge from ER
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mustafa Colak, MD contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Başakşehir Çam & Sakura City Hospital
Istanbul
Ramazan Guven, Professor Dr, +90 532 493 59 95, ramazanguven@gmail.com
- Recruiting
Dr.Suat Seren Chest Diseasees Hospital
Izmir, 35230
Cenk Kirakli, professor, ckirakli@hotmail.com
About this study
Official title: Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)- a Randomized Cross-over Study
High flow nasal oxygen therapy (HFNO) is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure. The high humidified gas flow supports patient's work of breathing, reduces dead space ventilation, and improves functional residual capacity while using an unobtrusive patient's face interface [Mauri et al, 2017; Möller et al, 2017].
As hyperoxia is considered not desirable [Barbateskovic et al, 2019] during any oxygen therapy, the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96% in patients without hypercapnia risk, and of 88-92% if a risk of hypercapnia is present [O'Driscoll et al, 2017; Beasley et al, 2015]. In most institutions, the standard of care is to manually adapt the FiO2, although patients frequently have a SpO2 value outside the target range.
Read more
A new closed loop oxygen controller designed for HFNO was recently developed (Hamilton Medical, Bonaduz, Switzerland). The clinician sets SpO2 targets, and the software option adjusts FiO2 to keep SpO2 within the target ranges. The software option offers some alarms on low and high SpO2 and high FiO2. Given the capability, on the one hand, to quickly increase FiO2 in patients developing sudden and profound hypoxia, and, on the other hand, of automatically preventing hyperoxia in patients improving their oxygenation, such a system could be particularly useful in patients treated with HFNO.
A short-term (4 hours vs 4 hours) crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy [Roca et al, 2022]. Due to its simplicity, HFNO is increasingly used outside the ICU during transport and in the Emergency Room (ER). This environment poses specific challenges, as patients may deteriorate very quickly and depending on patient's flow, healthcare providers can easily be overwhelmed. We thus propose to evaluate closed loop controlled HFNO in ER patients.
The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ER patients treated with HFNO.
- Conditions
- Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure, Respiratory Depression, Respiratory Failure
- Being tested
- Closed-loop FiO2 controller, Conventional
- Keywords
- Acute respiratory failure (ARF), HFNC, Closed-loop
- 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 FiO2 controllerDevice
Close-loop FiO2 controller software option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the FiO2 setting to keep the patient's SpO2 in the target range.
ConventionalDevice
Six hours period where the fraction of inspired oxygen (FiO2) delivered will be manually titrated by clinician based on SpO2 values obtained from the patient.
| Study group | Role | What they receive |
|---|---|---|
| Close-loop FiO2 Controller | Experimental | Six hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient. Receives: Device: Closed-loop FiO2 controller |
| Conventional | Active comparator | Six hours period where the fraction of inspired oxygen (FiO2) delivered will be manually titrated by clinician based on SpO2 values obtained from the patient. Receives: Device: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent in optimal SpO2 range
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
Measured: 6 hours
Secondary outcomes (13)
Percentage of time with SpO2 signal available
Time with SpO2 signal available
Measured: 6 hours
Percentage of time with SpO2 below target range
SpO2 values below the optimal range
Measured: 6 hours
Percentage of time with SpO2 above target range
SpO2 values above the optimal range
Measured: 6 hours
Percentage of time with SpO2 outside optimal range
SpO2 values outside the optimal range
Measured: 6 hours
Percentage of time with with FiO2 below 40%
Duration of time with FiO2 < 40 %
Measured: 6 hours
Percentage of time with with FiO2 above 60%
Duration of time with FiO2 > 60 %
Measured: 6 hours
Percentage of time with with FiO2 = 100%
Duration of time with FiO2 = 60 %
Measured: 6 hours
Mean SpO2/FiO2
Mean SpO2/FiO2
Measured: 6 hours
Number of events with SpO2 below of target range (duration >10 s)
Frequency of events with SpO2 below of target range (duration >10 s)
Measured: 6 hours
Number of events with SpO2 below of target range (duration >60 s)
Frequency of events with SpO2 below of target range (duration >60 s)
Measured: 6 hours
Number of events with SpO2 below the predefined low SpO2 emergency limit
Frequency of events with SpO2 below of the predefined low SpO2 emergency limit
Measured: 6 hours
Number of events with SpO2 above the predefined low SpO2 emergency limit
Frequency of events with SpO2 above of the predefined low SpO2 emergency limit
Measured: 6 hours
Total oxygen use
Amount of additional oxygen use
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start21 Mar 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxemic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- Hamilton Medical AG
- Responsible party
- Sponsor
- Investigators
- Ramazan Guven, Associate prof, Principal investigator, Basaksehir Cam Sakura city Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374589
- Sponsor's protocol ID
- 202303123
- Acronym
- CLOUDHFOT
- Status last verified
- Jan 2025
- First submitted
- 16 Apr 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sandal O, Ceylan G, Topal S, Hepduman P, Colak M, Novotni D, Soydan E, Karaarslan U, Atakul G, Schultz MJ, Agin H. Closed-loop oxygen control improves oxygenation in pediatric patients under high-flow nasal oxygen-A randomized crossover study. Front Med (Lausanne). 2022 Nov 16;9:1046902. doi: 10.3389/fmed.2022.1046902. eCollection 2022.
PubMed 36465920Roca O, Caritg O, Santafe M, Ramos FJ, Pacheco A, Garcia-de-Acilu M, Ferrer R, Schultz MJ, Ricard JD. Closed-loop oxygen control improves oxygen therapy in acute hypoxemic respiratory failure patients under high flow nasal oxygen: a randomized cross-over study (the HILOOP study). Crit Care. 2022 Apr 14;26(1):108. doi: 10.1186/s13054-022-03970-w.
PubMed 35422002Dijkman KP, Goos TG, Dieleman JP, Mohns T, van Pul C, Andriessen P, Kroon AA, Reiss IK, Niemarkt HJ. Predictive Intelligent Control of Oxygenation in Preterm Infants: A Two-Center Feasibility Study. Neonatology. 2023;120(2):235-241. doi: 10.1159/000527539. Epub 2022 Dec 8.
PubMed 36481622O'Driscoll BR, Kirton L, Weatherall M, Bakerly ND, Turkington P, Cook J, Beasley R. Effect of a lower target oxygen saturation range on the risk of hypoxaemia and elevated NEWS2 scores at a university hospital: a retrospective study. BMJ Open Respir Res. 2024 Feb 29;11(1):e002019. doi: 10.1136/bmjresp-2023-002019.
PubMed 38423953
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)- a Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT06374589
- Acronym / sponsor ID
- CLOUDHFOT / 202303123
- Conditions
- Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure, Respiratory Depression, Respiratory Failure
- Keywords
- Acute respiratory failure (ARF), HFNC, Closed-loop
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- Hamilton Medical AG
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 18 Apr 2024 (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.
High flow nasal oxygen therapy (HFNO) is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure. The high humidified gas flow supports patient's work of breathing, reduces dead space ventilation, and improves functional residual capacity while using an unobtrusive patient's face interface [Mauri et al, 2017; Möller et al, 2017].
As hyperoxia is considered not desirable [Barbateskovic et al, 2019] during any oxygen therapy, the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96% in patients without hypercapnia risk, and of 88-92% if a risk of hypercapnia is present [O'Driscoll et al, 2017; Beasley et al, 2015]. In most institutions, the standard of care is to manually adapt the FiO2, although patients frequently have a SpO2 value outside the target range.
A new closed loop oxygen controller designed for HFNO was recently developed (Hamilton Medical, Bonaduz, Switzerland). The clinician sets SpO2 targets, and the software option adjusts FiO2 to keep SpO2 within the target ranges. The software option offers some alarms on low and high SpO2 and high FiO2. Given the capability, on the one hand, to quickly increase FiO2 in patients developing sudden and profound hypoxia, and, on the other hand, of automatically preventing hyperoxia in patients improving their oxygenation, such a system could be particularly useful in patients treated with HFNO.
A short-term (4 hours vs 4 hours) crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy [Roca et al, 2022]. Due to its simplicity, HFNO is increasingly used outside the ICU during transport and in the Emergency Room (ER). This environment poses specific challenges, as patients may deteriorate very quickly and depending on patient's flow, healthcare providers can easily be overwhelmed. We thus propose to evaluate closed loop controlled HFNO in ER patients.
The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ER patients treated with HFNO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Close-loop FiO2 Controller | Experimental | Device: Closed-loop FiO2 controllerSix hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient. |
| Conventional | Active comparator | Device: ConventionalSix hours period where the fraction of inspired oxygen (FiO2) delivered will be manually titrated by clinician based on SpO2 values obtained from the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient admitted to the ER
- Requiring NHFO
- Requiring FiO2 ≥ 30% to keep SpO2 in the target ranges defined by the clinician
- Aged over 18 years
- 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 (18 listed)
- Patients who fulfil any of the following exclusion criteria are not eligible for study participation:
- Patient with indication for immediate CPAP, NIV, or invasive mechanical ventilation
- Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
- Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the Massimo SpO2 sensor, which is displayed by a red or orange color bar)
- Severe acidosis (pH ≤ 7.30)
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 FiO2 controllerClose-loop FiO2 controller software option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the FiO2 setting to keep the patient's SpO2 in the target range. | Device | Close-loop FiO2 Controller |
| ConventionalSix hours period where the fraction of inspired oxygen (FiO2) delivered will be manually titrated by clinician based on SpO2 values obtained from the patient. | Device | Conventional |
Primary outcome
Percentage of time spent in optimal SpO2 range
Time frame: 6 hours
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
13 secondary outcomes
Percentage of time with SpO2 signal available
Time frame: 6 hours
Percentage of time with SpO2 below target range
Time frame: 6 hours
Percentage of time with SpO2 above target range
Time frame: 6 hours
Percentage of time with SpO2 outside optimal range
Time frame: 6 hours
Percentage of time with with FiO2 below 40%
Time frame: 6 hours
Percentage of time with with FiO2 above 60%
Time frame: 6 hours
Percentage of time with with FiO2 = 100%
Time frame: 6 hours
Mean SpO2/FiO2
Time frame: 6 hours
Number of events with SpO2 below of target range (duration >10 s)
Time frame: 6 hours
Number of events with SpO2 below of target range (duration >60 s)
Time frame: 6 hours
Number of events with SpO2 below the predefined low SpO2 emergency limit
Time frame: 6 hours
Number of events with SpO2 above the predefined low SpO2 emergency limit
Time frame: 6 hours
Total oxygen use
Time frame: 6 hours
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 28 Jan 2025.
- Background: PubMed 36465920Sandal O, Ceylan G, Topal S, Hepduman P, Colak M, Novotni D, Soydan E, Karaarslan U, Atakul G, Schultz MJ, Agin H. Closed-loop oxygen control improves oxygenation in pediatric patients under high-flow nasal oxygen-A randomized crossover study. Front Med (Lausanne). 2022 Nov 16;9:1046902. doi: 10.3389/fmed.2022.1046902. eCollection 2022.
- Background: PubMed 35422002Roca O, Caritg O, Santafe M, Ramos FJ, Pacheco A, Garcia-de-Acilu M, Ferrer R, Schultz MJ, Ricard JD. Closed-loop oxygen control improves oxygen therapy in acute hypoxemic respiratory failure patients under high flow nasal oxygen: a randomized cross-over study (the HILOOP study). Crit Care. 2022 Apr 14;26(1):108. doi: 10.1186/s13054-022-03970-w.
- Background: PubMed 36481622Dijkman KP, Goos TG, Dieleman JP, Mohns T, van Pul C, Andriessen P, Kroon AA, Reiss IK, Niemarkt HJ. Predictive Intelligent Control of Oxygenation in Preterm Infants: A Two-Center Feasibility Study. Neonatology. 2023;120(2):235-241. doi: 10.1159/000527539. Epub 2022 Dec 8.
- Background: PubMed 38423953O'Driscoll BR, Kirton L, Weatherall M, Bakerly ND, Turkington P, Cook J, Beasley R. Effect of a lower target oxygen saturation range on the risk of hypoxaemia and elevated NEWS2 scores at a university hospital: a retrospective study. BMJ Open Respir Res. 2024 Feb 29;11(1):e002019. doi: 10.1136/bmjresp-2023-002019.
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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.
Mustafa Colak, MD contact
Ramazan Guven, Associate prof principal investigator
Basaksehir Cam Sakura city Hospital, Istanbul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional in people with Acute Hypoxemic Respiratory Failure and Acute Hypercapnic Respiratory Failure, run by Başakşehir Çam & Sakura City Hospital at 2 sites in Turkey (Türkiye).
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 6 inclusion and 18 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Contact Ramazan Guven, Associate prof (05354935995, drramazanguven@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time spent in optimal SpO2 range (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06374589, which also lists 4 linked publications.
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 28 Jan 2025.