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

NCT05032365 | Completed

• 1 other identifier: 604/2021/13-01/
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Failure

Keywords

Acute respiratory failure (ARF); Pediatric acute respiratory distress syndrome (PARDS),; oxygen; Closed-loop

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent in optimal SpO2 range

  The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.

  2 hours

Secondary Outcomes (9)

• Percentage of time spent in sub-optimal SpO2 range

  2 hours

• Mean FiO2

  2 hours

• Mean SpO2/FiO2

  2 hours

• Number of manual adjustments

  2 hours

• Number of alarms

  2 hours

Study Arms (2)

Close-loop FiO2 Controller

EXPERIMENTAL

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

Conventional

ACTIVE COMPARATOR

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

Interventions

Close-loop FiO2 controller DEVICE

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.

Close-loop FiO2 Controller

Conventional DEVICE

Conventional FiO2 adjustment by the clinician according to SpO2 values

Conventional

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (2)

Erzurum Regional Research and Training Hospital

Erzurum, 25180, Turkey (Türkiye)

Location

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

Izmir, 35200, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 28936698 BACKGROUND

• 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.

  PMID: 29296004 BACKGROUND

• 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.

  PMID: 30464005 BACKGROUND

• 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.

  PMID: 26144575 BACKGROUND

• 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.

  PMID: 29726010 BACKGROUND

• 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.

  PMID: 31630690 BACKGROUND

• Sandal O, Ceylan G, Topal S, Hepduman P, Colak M, Novotni D, Soydan E, Karaarslan U, Atakul G, Schultz MJ, Agin H. Closed-loop oxygen control improves oxygenation in pediatric patients under high-flow nasal oxygen-A randomized crossover study. Front Med (Lausanne). 2022 Nov 16;9:1046902. doi: 10.3389/fmed.2022.1046902. eCollection 2022.

  PMID: 36465920 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor, Head of pediatric intensive care unit (PICU)

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 2, 2021
• Study Start: September 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

TU (2)