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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Başakşehir Çam & Sakura City Hospital
RECRUITING
Istanbul
Dr.Suat Seren Chest Diseasees Hospital
RECRUITING
Izmir
Contact Information
Primary
Ramazan Guven, Associate prof
drramazanguven@gmail.com
05354935995
Backup
Mustafa Colak, MD
colakk@hotmail.com.tr
Time Frame
Start Date: 2024-03-21
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 50
Treatments
Experimental: Close-loop FiO2 Controller
Six hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient.
Active_comparator: Conventional
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.
Related Therapeutic Areas
Sponsors
Leads: Başakşehir Çam & Sakura City Hospital
Collaborators: Hamilton Medical AG

This content was sourced from clinicaltrials.gov