Closed-loop FiO2 Controller During High Flow Oxygen Treatment In Pediatric Patients (COFICOHFOT)

NCT ID: NCT05032365

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-02-01

Brief Summary

Recently, high flow oxygen therapy (HFOT) is becoming more popular in the treatment of any kind of respiratory failure. Pediatric mechanical ventilation consensus conference (PEMVECC) guidelines suggest measuring oxygen saturation by pulse oximetry (SpO2) in all ventilated children and furthermore to measure partial arterial oxygen pressure (PaO2) in moderate-to-severe disease in order to prevent excessive use of oxygen while preventing hypoxemia and hyperoxemia. This study aims to compare the safety and efficacy of a closed-loop FiO2 controller (CLOC) with conventional control of FiO2 during HFOT of pediatric patients in a pediatric intensive care unit (PICU). The hypothesis of this study is: Close-loop FiO2 controller 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 PICU patients treated with HFOT.

Conditions

Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Close-loop FiO2 Controller

Two hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient.

Group Type: EXPERIMENTAL

Close-loop FiO2 controller

Intervention Type: 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.

Conventional

Two hours period where the FiO2 delivered will be conventionally adjusted by the healthcare personnel based on SpO2 values obtained from the patient.

Group Type: ACTIVE_COMPARATOR

Conventional

Intervention Type: DEVICE

Conventional FiO2 adjustment by the clinician according to SpO2 values

Interventions

Close-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.

Intervention Type: DEVICE

Conventional

Conventional FiO2 adjustment by the clinician according to SpO2 values

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Pediatric patients older than 1 month and younger than18 years of age; hospitalized at the PICU with the intention of treatment with HFOT at least for the upcoming 5 hours
• Requiring FiO2 ≥ 25% to keep SpO2 in the target ranges defined by the clinician
• 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

Exclusion Criteria

• Patient with indication for immediate noninvasive ventilation (NIMV), or invasive mechanical ventilation (IMV)
• 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 SpO2 sensor, which is displayed by a red or orange colour bar)
• Severe acidosis (pH ≤ 7.25)
• Pregnant woman
• Patients deemed at high risk for the need of mechanical ventilation within the next 5 hours
• Patients deemed at high risk for the need of transportation from PICU to another ward, diagnostic unit or any other hospital
• Diseases or conditions which may affect transcutaneous SpO2 measurement such as chronic or acute dyshemoglobinemia: methemoglobinemia, carbon monoxide (CO) poisoning, sickle cell disease
• Formalized ethical decision to withhold or withdraw life support
• Patient included in another interventional research study under consent
• Patient already enrolled in the present study in a previous episode of acute respiratory failure

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Behcet Uz Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hasan ağın

Professor doctor, Head of pediatric intensive care unit (PICU)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erzurum Regional Research and Training Hospital

Erzurum, , Turkey (Türkiye)

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 36465920 (View on PubMed)

Other Identifiers

604/2021/13-01/

Identifier Type: -

Identifier Source: org_study_id