Closed-loop Synchronization Versus Conventional Synchronization

Launched by DR. BEHCET UZ CHILDREN'S HOSPITAL · Feb 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to help children who need breathing support with a machine called a ventilator. One method is called closed-loop synchronization, which automatically adjusts the ventilator to better match the child's natural breathing. The other method is conventional synchronization, which is the standard way we currently manage ventilator settings. The goal is to see which method is safer and more effective for children with serious breathing issues in the pediatric intensive care unit (PICU).

To be eligible for this study, children must be between 1 month and 18 years old and need mechanical ventilation for at least the next three hours. A parent or guardian must provide written consent for their child to participate. If a child joins the study, they can expect to receive either the new closed-loop method or the standard method of ventilation. It's important to note that this study is only for children who are stable and not facing critical situations that could prevent them from participating. Overall, this trial aims to improve how we support young patients with respiratory problems and help them breathe better while they are receiving care.

Gender

ALL

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 mechanical ventilation at least for the upcoming 3 hours with spontaneous breathing activity
• • 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:
• • 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 respiratory failure
• • Pregnant woman
• • Patients deemed at high risk for the need of transportation from PICU to another ward, diagnostic unit or any other hospital
• • Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h
• • Not being able to obtain reference waveform