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

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Device: Close-loop FiO2 controller; Device: Conventional

• Registration Number: NCT05714527
• Lead Sponsor: Dr. Behcet Uz Children's Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Study Start: 2023-01-30
• Study First Posted: 2023-02-06
• Primary Completion: 2023-12-31
• Study Completion: 2024-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Close-loop FiO2 Controller	Close-loop FiO2 controller	Two hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient.
Conventional	Conventional	Conventional FiO2 adjustment by the clinician according to SpO2 values

Primary Outcome Measures

Name	Time	Method
Percentage of time spent in optimal SpO2 range	2 hours	The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Aydin Obstetric and pediatrics Hospital; 🇹🇷 Aydın, Turkey

Erzurum Regional Research and Training Hospital; 🇹🇷 Erzurum, Turkey

Cam Sakura Research and Training Hospital; 🇹🇷 Istanbul, Turkey

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital; 🇹🇷 Izmir, Turkey