Clinical Trial

Closed-loop Synchronization Versus Conventional Synchronization

Study acronym: CHESTSIPP
Recruiting
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Record status
This record was last updated March 19, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
A prior research indicated that asynchrony between the patient and ventilator occurred in 33 percent of 19,175 breaths, and was seen in every patient. The most prevalent kind of asynchrony was ineffective triggering (68%), followed by delayed termination (19%), double triggering (4%) and premature termination (3%). Asynchrony between the patient and ventilator increased considerably with decreasing levels of peak inspiratory pressure, positive end-expiratory pressure, and set frequency.Despite this, more asynchrony categories exist, and there is no widely accepted categorization. Major asynchronies, however, include auto trigger, ineffective effort, and double trigger, while minor asynchronies include early/late cycle, trigger delay, and spontaneous breaths during a mandatory breath. This study aims to compare the safety and efficacy of a closed-loop synchronization controller with conventional control of synchronization during invasive mechanical ventilation of spontaneous breathing of pediatric patients in a pediatric intensive care unit (PICU).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-02-15; most recent amendment 2025-03-18.
Status change: Not Yet Recruiting → Recruiting 2023-09-14
Trial Details
NCT Number NCT05731024
Lead Sponsor Dr. Behcet Uz Children's Hospital
Collaborators: Hamilton Medical AG
Conditions Acute Respiratory Failure, Pediatric Respiratory Distress Syndrome
Enrollment 15 participants
Start Date 2023-02-06
Primary Completion 2025-11-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-19