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

Not Applicable

Completed

• Conditions: Respiratory Failure

• Registration Number: NCT05032365
• Lead Sponsor: Dr. Behcet Uz Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-08-31
• Study Start: 2021-09-01
• Study First Posted: 2021-09-02
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Percentage of time spent in optimal SpO2 range	2 hours	The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.

Secondary Outcome Measures

Name	Time	Method
Percentage of time spent in sub-optimal SpO2 range	2 hours	SpO2 values outside the optimal range but still within an acceptable limit (2-3 percent above and below the optimal range)
Mean FiO2	2 hours	Mean fraction of inspired oxygen
Mean SpO2/FiO2	2 hours	Mean SpO2/FiO2 oxygen
Number of manual adjustments	2 hours	Frequency of manual adjustments of FiO2
Number of alarms	2 hours	Frequency of alarms
Percentage of time with SpO2 signal available	2 hours	Time with SpO2 signal available
Percentage of time with SpO2 below 88 and 85 percent	2 hours	Duration of time with SpO2 \<85 percent and \<88 percent, respectively
Number of events with SpO2 below 88 and 85 percent	2 hours	Frequency of SpO2 decreases \<85 percent and \<88 percent, respectively
Percentage of time with FiO2 below 40 percent, 60 percent and 100 percent	2 hours	Percentage of time that FiO2 is \<40 percent, 60 percent and 100 percent, respectively

Trial Locations

Locations (2)

Erzurum Regional Research and Training Hospital; 🇹🇷 Erzurum, Turkey

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital; 🇹🇷 Izmir, Turkey