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

NCT06374589 | Recruiting

• 1 other identifier: 202303123
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Hypoxemic Respiratory Failure; Acute Hypercapnic Respiratory Failure; Respiratory Depression; Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Percentage of time with SpO2 signal available

  6 hours

• Percentage of time with SpO2 below target range

  6 hours

• Percentage of time with SpO2 above target range

  6 hours

• Percentage of time with SpO2 outside optimal range

  6 hours

• Percentage of time with with FiO2 below 40%

  6 hours

Study Arms (2)

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.

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.

Device: Conventional

Interventions

Closed-loop FiO2 controller DEVICE

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.

Close-loop FiO2 Controller

Conventional DEVICE

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.

Conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Apparition of a persistent low quality SpO2 signal
• Need for an emergent intubation

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead
• Hamilton Medical AG: collaborator

Study Sites (2)

Başakşehir Çam & Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Dr.Suat Seren Chest Diseasees Hospital

Izmir, 35230, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 36465920 BACKGROUND

• 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.

  PMID: 35422002 BACKGROUND

• 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.

  PMID: 36481622 BACKGROUND

• 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.

  PMID: 38423953 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ramazan Guven, Associate prof

  Basaksehir Cam Sakura city Hospital, Istanbul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramazan Guven, Associate prof

CONTACT

05354935995; drramazanguven@gmail.com

Mustafa Colak, MD

CONTACT

colakk@hotmail.com.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: March 21, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

TU (2)