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Respiratory FailureCOFICOHFOTNCT05032365

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

A study testing Conventional in people with Respiratory Failure, run by Dr. Behcet Uz Children's Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
Respiratory Failure
What is being tested?
Conventional
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Sep 2021to 1 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Erzurum Regional Research and Training Hospital

    Erzurum, 25180

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

    Izmir, 35200

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
Close-loop FiO2 controller, Conventional
Keywords
Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS),, oxygen, Closed-loop
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Close-loop FiO2 controllerDevice

    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.

  • ConventionalDevice

    Conventional FiO2 adjustment by the clinician according to SpO2 values

Study groups in NCT05032365
Study groupRoleWhat they receive
Close-loop FiO2 ControllerExperimentalTwo hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient.
Receives: Device: Close-loop FiO2 controller
ConventionalActive comparatorTwo hours period where the FiO2 delivered will be conventionally adjusted by the healthcare personnel based on SpO2 values obtained from the patient.
Receives: Device: Conventional

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 hours

Secondary outcomes (9)

  1. 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)

    Measured: 2 hours

  2. Mean FiO2

    Mean fraction of inspired oxygen

    Measured: 2 hours

  3. Mean SpO2/FiO2

    Mean SpO2/FiO2 oxygen

    Measured: 2 hours

  4. Number of manual adjustments

    Frequency of manual adjustments of FiO2

    Measured: 2 hours

  5. Number of alarms

    Frequency of alarms

    Measured: 2 hours

  6. Percentage of time with SpO2 signal available

    Time with SpO2 signal available

    Measured: 2 hours

  7. Percentage of time with SpO2 below 88 and 85 percent

    Duration of time with SpO2 <85 percent and <88 percent, respectively

    Measured: 2 hours

  8. Number of events with SpO2 below 88 and 85 percent

    Frequency of SpO2 decreases <85 percent and <88 percent, respectively

    Measured: 2 hours

  9. 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

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2021
  2. Study start1 Sep 2021
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05032365
Sponsor's protocol ID
604/2021/13-01/
Acronym
COFICOHFOT
Status last verified
Jan 2023
First submitted
31 Aug 2021
Last updated
30 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28936698

  • 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.

    PubMed 29296004

  • 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.

    PubMed 30464005

  • 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.

    PubMed 26144575

  • 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.

    PubMed 29726010

  • 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.

    PubMed 31630690

  • 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.

    PubMed 36465920

Questions about this trial

What is this clinical trial studying?

A study testing Conventional in people with Respiratory Failure, run by Dr. Behcet Uz Children's Hospital at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time spent in optimal SpO2 range (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05032365, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.

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COFICOHFOT Clinical Trial NCT05032365 | AzTrials