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

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ClinicalTrials.gov Identifier: NCT05032365
Recruitment Status : Recruiting
First Posted : September 2, 2021
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Hasan ağın, 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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: Close-loop FiO2 controller Device: Conventional Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. Mean FiO2 [ Time Frame: 2 hours ]
    Mean fraction of inspired oxygen

  3. Mean SpO2/FiO2 [ Time Frame: 2 hours ]
    Mean SpO2/FiO2 oxygen

  4. Number of manual adjustments [ Time Frame: 2 hours ]
    Frequency of manual adjustments of FiO2

  5. Number of alarms [ Time Frame: 2 hours ]
    Frequency of alarms

  6. Percentage of time with SpO2 signal available [ Time Frame: 2 hours ]
    Time with SpO2 signal available

  7. 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

  8. Number of events with SpO2 below 88 and 85 percent [ Time Frame: 2 hours ]
    Frequency of SpO2 decreases <85 percent and <88 percent, respectively

  9. 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



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05032365


Contacts
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Contact: Hasan Agin, Professor +905362013162 hasanagin@gmail.com
Contact: Gokhan Ceylan, MD 0794542397 drgokhanceylan@gmail.com

Locations
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Turkey
Erzurum Regional Research and Training Hospital Recruiting
Erzurum, Turkey, 25180
Contact: Sevgi Topal, MD    +905078645922      
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital Recruiting
Izmir, Turkey, 35200
Contact: Ozlem Sandal, MD    +905067644688    drozlemsarac@hotmail.com   
Sub-Investigator: Ozlem Sandal         
Sponsors and Collaborators
Dr. Behcet Uz Children's Hospital
Publications:

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Responsible Party: Hasan ağın, Professor doctor, Head of pediatric intensive care unit (PICU), Dr. Behcet Uz Children's Hospital
ClinicalTrials.gov Identifier: NCT05032365    
Other Study ID Numbers: 604/2021/13-01/
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hasan ağın, Dr. Behcet Uz Children's Hospital:
Acute respiratory failure (ARF)
Pediatric acute respiratory distress syndrome (PARDS),
oxygen
Closed-loop
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases