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

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.

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 Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Acute Hypoxemic Respiratory Failure; Acute Hypercapnic Respiratory Failure; Respiratory Depression
• Intervention / Treatment: Device: Closed-loop FiO2 controller; Device: Conventional

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramazan Guven, Associate prof; Phone Number: 05354935995; Email: drramazanguven@gmail.com
• Study Contact Backup: Name: Mustafa Colak, MD; Email: colakk@hotmail.com.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Başakşehir Çam & Sakura City Hospital
    • Contact: Ramazan Guven, Professor Dr; Phone Number: +90 532 493 59 95; Email: ramazanguven@gmail.com
  • Izmir, Turkey, 35230
    • Recruiting
    • Dr.Suat Seren Chest Diseasees Hospital
    • Contact: Cenk Kirakli, professor; Email: ckirakli@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Closed-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.
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time spent in optimal SpO2 range	The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time with SpO2 signal available	Time with SpO2 signal available	6 hours
Percentage of time with SpO2 below target range	SpO2 values below the optimal range	6 hours
Percentage of time with SpO2 above target range	SpO2 values above the optimal range	6 hours
Percentage of time with SpO2 outside optimal range	SpO2 values outside the optimal range	6 hours
Percentage of time with with FiO2 below 40%	Duration of time with FiO2 < 40 %	6 hours
Percentage of time with with FiO2 above 60%	Duration of time with FiO2 > 60 %	6 hours
Percentage of time with with FiO2 = 100%	Duration of time with FiO2 = 60 %	6 hours
Mean SpO2/FiO2	Mean SpO2/FiO2	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)	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)	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	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	6 hours
Total oxygen use	Amount of additional oxygen use	6 hours

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital
• Collaborators: Hamilton Medical AG
• Investigators: Principal Investigator: Ramazan Guven, Associate prof, Basaksehir Cam Sakura city Hospital, Istanbul

Publications and helpful links

General 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.
• Roca 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.
• Dijkman 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.
• O'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.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: HFNC; Closed-loop; Acute respiratory failure (ARF)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 202303123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No