Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06374589

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

Led by Başakşehir Çam & Sakura City Hospital · Updated on 2025-01-28

50

Participants Needed

2

Research Sites

114 weeks

Total Duration

On this page

Sponsors

B

Başakşehir Çam & Sakura City Hospital

Lead Sponsor

H

Hamilton Medical AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 if patient unable to consent
  • Patient consent will be requested when able if initially given by a relative
Not Eligible

You will not qualify if you...

  • Indication for immediate CPAP, NIV, or invasive mechanical ventilation
  • Hemodynamic instability needing continuous infusion of epinephrine or norepinephrine > 1 mg/h
  • Low quality SpO2 measurement (quality index below 60% on Massimo SpO2 sensor)
  • Severe acidosis with pH  7.30
  • Pregnant woman
  • High risk for mechanical ventilation within next 12 hours
  • Chronic or acute dyshemoglobinemia including methemoglobin, CO poisoning, sickle cell disease
  • Tracheotomized patient
  • Ethical decision to withhold or withdraw life support
  • Patient under guardianship
  • Patient deprived of liberties
  • Participation in another interventional study under consent
  • Previously enrolled in this study during a prior acute respiratory failure episode
  • Post enrollment exclusion: persistent low quality SpO2 signal, emergent intubation, or discharge from ER

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Başakşehir Çam & Sakura City Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

2

Dr.Suat Seren Chest Diseasees Hospital

Izmir, Turkey (Türkiye), 35230

Actively Recruiting

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Research Team

R

Ramazan Guven, Associate prof

CONTACT

M

Mustafa Colak, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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