Clinical trial NCT05032365: Closed-loop FiO2 Controller During High Flow Oxygen Treatment In Pediatric Patients (COFICOHFOT)
Official title: Randomized Crossover Trial To Compare Closed-loop FiO2 Controller With Conventional Control of FiO2 During High Flow Oxygen Treatment In Pediatric Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: Acute respiratory failure (ARF)
Pediatric acute respiratory distress syndrome (PARDS),
oxygen
Closed-loop
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 23
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of time spent in optimal SpO2 range
timeFrame: 2 hours
Secondary outcomes:
measure: Percentage of time spent in sub-optimal SpO2 range
timeFrame: 2 hours
measure: Mean FiO2
timeFrame: 2 hours
measure: Mean SpO2/FiO2
timeFrame: 2 hours
measure: Number of manual adjustments
timeFrame: 2 hours
measure: Number of alarms
timeFrame: 2 hours
measure: Percentage of time with SpO2 signal available
timeFrame: 2 hours
measure: Percentage of time with SpO2 below 88 and 85 percent
timeFrame: 2 hours
measure: Number of events with SpO2 below 88 and 85 percent
timeFrame: 2 hours
measure: Percentage of time with FiO2 below 40 percent, 60 percent and 100 percent
timeFrame: 2 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Regional Research and Training Hospital
city: Izmir
country: Turkey
facility: The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Study officials:
References:
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