Comparing closed-loop and conventional methods for ventilator synchronization in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and efficacy of a closed-loop synchronization controller compared to conventional synchronization methods during invasive mechanical ventilation in pediatric patients. It focuses on children aged 1 month to 18 years who are hospitalized in the Pediatric Intensive Care Unit (PICU) and require mechanical ventilation for at least three hours. The study will assess the occurrence of patient-ventilator asynchrony, which can lead to complications in respiratory management. Participants will be monitored for their response to both synchronization methods to determine which is more effective in improving patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Aydin Obstetric and pediatrics Hospital
  Aydin, Turkey (Türkiye) Recruiting
• Erzurum Regional Research and Training Hospital
  Erzurum, Turkey (Türkiye) Recruiting
• Erzurum Regional Research and Training Hospital
  Erzurum, Turkey (Türkiye) Recruiting
• Cam Sakura Research and Training Hospital
  Istanbul, Turkey (Türkiye) Recruiting
• The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
  Izmir, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Hasan Agin, Professor — Behcet Uz Children's Hospital
• Study coordinator: Hasan Agin, Professor
• Email: hasanagin@gmail.com
• Phone: +905362013162

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.