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Completed

NCT Number: NCT05714527

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

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

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aydin Obstetric and pediatrics Hospital, Aydin, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients older than 1 month and younger than18 years of age; hospitalized at the PICU with the intention of treatment with IMV 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), High flow oxygen therapy (HFOT)
  • 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 non-invasive 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

Treatment and study plan

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.

Conventional

Device

Conventional FiO2 adjustment by the clinician according to SpO2 values, by using the manual FiO2 knob.

Primary outcomes

  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 outcomes

  1. Percentage of time spent in suboptimal 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

  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

  10. Total oxygen use

    Time frame: 2 hours

    Volume of total oxygen used (in L)

Sponsors and collaborators

Lead sponsor

Dr. Behcet Uz Children's Hospital

Other

Collaborators

  • Hamilton Medical AG

Registry information

Official study title

Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients (CLOUDIMPP)- a Randomized Cross-over Study

Acronym: CLOUDIMPP

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 6, 2023
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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