Skip to content

Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)

Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)- a Randomized Cross-over Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06374589
Acronym
CLOUDHFOT
Enrollment
50
Registered
2024-04-18
Start date
2024-03-21
Completion date
2026-05-30
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure, Respiratory Depression, Respiratory Failure

Keywords

Acute respiratory failure (ARF), HFNC, Closed-loop

Brief 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 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.

Interventions

DEVICEClosed-loop FiO2 controller

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.

DEVICEConventional

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.

Sponsors

Hamilton Medical AG
CollaboratorINDUSTRY
Başakşehir Çam & Sakura City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

Patients who fulfil any of the following

Design outcomes

Primary

MeasureTime frameDescription
Percentage of time spent in optimal SpO2 range6 hoursThe optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.

Secondary

MeasureTime frameDescription
Percentage of time with SpO2 below target range6 hoursSpO2 values below the optimal range
Percentage of time with SpO2 above target range6 hoursSpO2 values above the optimal range
Percentage of time with SpO2 outside optimal range6 hoursSpO2 values outside the optimal range
Percentage of time with with FiO2 below 40%6 hoursDuration of time with FiO2 \< 40 %
Percentage of time with with FiO2 above 60%6 hoursDuration of time with FiO2 \> 60 %
Percentage of time with with FiO2 = 100%6 hoursDuration of time with FiO2 = 60 %
Percentage of time with SpO2 signal available6 hoursTime with SpO2 signal available
Number of events with SpO2 below of target range (duration >10 s)6 hoursFrequency of events with SpO2 below of target range (duration \>10 s)
Number of events with SpO2 below of target range (duration >60 s)6 hoursFrequency of events with SpO2 below of target range (duration \>60 s)
Number of events with SpO2 below the predefined low SpO2 emergency limit6 hoursFrequency of events with SpO2 below of the predefined low SpO2 emergency limit
Number of events with SpO2 above the predefined low SpO2 emergency limit6 hoursFrequency of events with SpO2 above of the predefined low SpO2 emergency limit
Total oxygen use6 hoursAmount of additional oxygen use
Mean SpO2/FiO26 hoursMean SpO2/FiO2

Countries

Turkey (Türkiye)

Contacts

Primary ContactRamazan Guven, Associate prof
drramazanguven@gmail.com05354935995
Backup ContactMustafa Colak, MD
colakk@hotmail.com.tr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026