Closed-Loop O2 Use During Invasive Mechanical Ventilation Of Pediatric Patients (CLOUDIMPP)
Respiratory Failure
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS), Closed-loop, Oxygen, SpO2
Eligibility Criteria
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
Sites / Locations
- Aydin Obstetric and pediatrics HospitalRecruiting
- Erzurum Regional Research and Training HospitalRecruiting
- Cam Sakura Research and Training HospitalRecruiting
- The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Close-loop FiO2 Controller
Conventional
Two hours period where the fraction of inspired oxygen (FiO2) delivered will be automatically titrated based on SpO2 values obtained from the patient.
Conventional FiO2 adjustment by the clinician according to SpO2 values