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Closed-loop Synchronization Versus Conventional Synchronization

Study acronym: CHESTSIPP
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Notable Primary completion date: Nov 30, 2024 to Nov 30, 2025
    • Study completion date: Dec 30, 2024 to Dec 30, 2025
    v4
  2. Notable Primary completion date: Nov 30, 2023 to Nov 30, 2024
    • Study completion date: Dec 30, 2023 to Dec 30, 2024
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 4 to 5
    • Primary completion date: Jun 30, 2023 to Nov 30, 2023
    • Study completion date: Sep 30, 2023 to Dec 30, 2023
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05731024
Lead Sponsor Dr. Behcet Uz Children's Hospital
Collaborators: Hamilton Medical AG
Conditions
(from sponsor)
Acute Respiratory Failure, Pediatric Respiratory Distress Syndrome
Related terms Patient-Ventilator Asynchrony, Respiratory Distress Syndrome
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov