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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Close-loop FiO2 controller
Conventional
Sponsored by
Dr. Behcet Uz Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS),, oxygen, Closed-loop

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Close-loop FiO2 Controller

Conventional

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 31, 2021
Last Updated
January 27, 2023
Sponsor
Dr. Behcet Uz Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05032365
Brief Title
Closed-loop FiO2 Controller During High Flow Oxygen Treatment In Pediatric Patients (COFICOHFOT)
Acronym
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Behcet Uz Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS),, oxygen, Closed-loop

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Close-loop FiO2 Controller
Arm Type
Experimental
Arm Description
Two hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Two hours period where the FiO2 delivered will be conventionally adjusted by the healthcare personnel based on SpO2 values obtained from the patient.
Intervention Type
Device
Intervention Name(s)
Close-loop FiO2 controller
Intervention Description
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
Intervention Name(s)
Conventional
Intervention Description
Conventional FiO2 adjustment by the clinician according to SpO2 values
Primary Outcome Measure Information:
Title
Percentage of time spent in optimal SpO2 range
Description
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Percentage of time spent in sub-optimal SpO2 range
Description
SpO2 values outside the optimal range but still within an acceptable limit (2-3 percent above and below the optimal range)
Time Frame
2 hours
Title
Mean FiO2
Description
Mean fraction of inspired oxygen
Time Frame
2 hours
Title
Mean SpO2/FiO2
Description
Mean SpO2/FiO2 oxygen
Time Frame
2 hours
Title
Number of manual adjustments
Description
Frequency of manual adjustments of FiO2
Time Frame
2 hours
Title
Number of alarms
Description
Frequency of alarms
Time Frame
2 hours
Title
Percentage of time with SpO2 signal available
Description
Time with SpO2 signal available
Time Frame
2 hours
Title
Percentage of time with SpO2 below 88 and 85 percent
Description
Duration of time with SpO2 <85 percent and <88 percent, respectively
Time Frame
2 hours
Title
Number of events with SpO2 below 88 and 85 percent
Description
Frequency of SpO2 decreases <85 percent and <88 percent, respectively
Time Frame
2 hours
Title
Percentage of time with FiO2 below 40 percent, 60 percent and 100 percent
Description
Percentage of time that FiO2 is <40 percent, 60 percent and 100 percent, respectively
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Erzurum Regional Research and Training Hospital
City
Erzurum
ZIP/Postal Code
25180
Country
Turkey
Facility Name
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
City
Izmir
ZIP/Postal Code
35200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28936698
Citation
Kneyber MCJ, de Luca D, Calderini E, Jarreau PH, Javouhey E, Lopez-Herce J, Hammer J, Macrae D, Markhorst DG, Medina A, Pons-Odena M, Racca F, Wolf G, Biban P, Brierley J, Rimensberger PC; section Respiratory Failure of the European Society for Paediatric and Neonatal Intensive Care. Recommendations for mechanical ventilation of critically ill children from the Paediatric Mechanical Ventilation Consensus Conference (PEMVECC). Intensive Care Med. 2017 Dec;43(12):1764-1780. doi: 10.1007/s00134-017-4920-z. Epub 2017 Sep 22.
Results Reference
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PubMed Identifier
29296004
Citation
Mitra S, Singh B, El-Naggar W, McMillan DD. Automated versus manual control of inspired oxygen to target oxygen saturation in preterm infants: a systematic review and meta-analysis. J Perinatol. 2018 Apr;38(4):351-360. doi: 10.1038/s41372-017-0037-z. Epub 2018 Jan 2.
Results Reference
background
PubMed Identifier
30464005
Citation
Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21.
Results Reference
background
PubMed Identifier
26144575
Citation
van Kaam AH, Hummler HD, Wilinska M, Swietlinski J, Lal MK, te Pas AB, Lista G, Gupta S, Fajardo CA, Onland W, Waitz M, Warakomska M, Cavigioli F, Bancalari E, Claure N, Bachman TE. Automated versus Manual Oxygen Control with Different Saturation Targets and Modes of Respiratory Support in Preterm Infants. J Pediatr. 2015 Sep;167(3):545-50.e1-2. doi: 10.1016/j.jpeds.2015.06.012. Epub 2015 Jul 2.
Results Reference
background
PubMed Identifier
29726010
Citation
Lui K, Jones LJ, Foster JP, Davis PG, Ching SK, Oei JL, Osborn DA. Lower versus higher oxygen concentrations titrated to target oxygen saturations during resuscitation of preterm infants at birth. Cochrane Database Syst Rev. 2018 May 4;5(5):CD010239. doi: 10.1002/14651858.CD010239.pub2.
Results Reference
background
PubMed Identifier
31630690
Citation
Maiwald CA, Niemarkt HJ, Poets CF, Urschitz MS, Konig J, Hummler H, Bassler D, Engel C, Franz AR; FiO2-C Study Group. Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants - study protocol of a randomized controlled parallel group multicenter trial for safety and efficacy. BMC Pediatr. 2019 Oct 21;19(1):363. doi: 10.1186/s12887-019-1735-9.
Results Reference
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Closed-loop FiO2 Controller During High Flow Oxygen Treatment In Pediatric Patients (COFICOHFOT)

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