Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients

Last updated: October 28, 2024
Sponsor: Dr. Behcet Uz Children's Hospital
Overall Status: Completed

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

Close-loop FiO2 controller

Conventional

Clinical Study ID

NCT05714527
2022/750
  • Ages 1-18
  • All Genders

Study Summary

During mechanical ventilation (MV) hypoxemic or hyperoxemic events should be carefully monitored and a quick response should be provided by the caregiver at the bedside. Pediatric mechanical ventilation consensus conference (PEMVECC) guidelines suggest to measure SpO2 in all ventilated children and furthermore to measure partial arterial oxygen pressure (PaO2) in moderate-to-severe disease. There were no predefined upper and lower limits for oxygenation in pediatric guidelines, however, Pediatric acute lung injury consensus conference PALICC guidelines proposed SpO2 between 92 - 97% when positive end-expiratory pressure (PEEP) is smaller than 10 cm H2O and SpO2 of 88 - 92% when PEEP is bigger or equal to 10 cm H2O. For healthy lung, PEMVECC proposed the SpO2>95% when breathing a FiO2 of 21%. As a rule of thumb, the minimum fraction of inspired O2 (FiO2) to reach these targets should be used. A recent Meta-analyze showed that automated FiO2 adjustment provides a significant improvement of time in target saturations, reduces periods of hyperoxia, and severe hypoxia in preterm infants on positive pressure respiratory support. This study aims to compare the closed-loop FiO2 controller with conventional control of FiO2 during mechanical ventilation of pediatric patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pediatric patients older than 1 month and younger than18 years of age; hospitalizedat the PICU with the intention of treatment with IMV at least for the upcoming 5hours

  • 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 casethat the patient is unable to consent, after full explanation of the study by theinvestigator and prior to study participation

Exclusion

Exclusion Criteria:

  • Patient with indication for immediate noninvasive ventilation (NIMV), High flowoxygen therapy (HFOT)

  • Hemodynamic instability defined as a need of continuous infusion of epinephrine ornorepinephrine > 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 non-invasive mechanical ventilationwithin the next 5 hours

  • Patients deemed at high risk for the need of transportation from PICU to anotherward, diagnostic unit or any other hospital

  • Diseases or conditions which may affect transcutaneous SpO2 measurement such aschronic 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 acuterespiratory failure

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Close-loop FiO2 controller
Phase:
Study Start date:
January 30, 2023
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • Aydin Obstetric and pediatrics Hospital

    Aydın, 09020
    Turkey

    Site Not Available

  • Erzurum Regional Research and Training Hospital

    Erzurum, 25180
    Turkey

    Site Not Available

  • Cam Sakura Research and Training Hospital

    Istanbul, 34001
    Turkey

    Site Not Available

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

    Izmir, 35200
    Turkey

    Site Not Available

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