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

January 27, 2023 updated by: Hasan ağın, Dr. Behcet Uz Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25180
        • Erzurum Regional Research and Training Hospital
      • Izmir, Turkey, 35200
        • The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Active Comparator: Conventional
Two hours period where the FiO2 delivered will be conventionally adjusted by the healthcare personnel based on SpO2 values obtained from the patient.
Device: Conventional
Conventional FiO2 adjustment by the clinician according to SpO2 values

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time spent in optimal SpO2 range
Time Frame: 2 hours
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
2 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Behcet Uz Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 2, 2021

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 604/2021/13-01/

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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