Closed-loop Synchronization Versus Conventional Synchronization

Condition(s) studied

Investigational drug(s) / intervention(s)

close-loop synchronization controller with SPONT mode: One-hour period where the pressure support of spontaneous breath will be automatically titrated based on pressure and flow waveform analysis obtained from the patient.

Conventional synchronization settings with SPONT mode: One-hour period where the pressure support of spontaneous breath will be manually set.

Study 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).

Eligibility

Primary outcome measure(s)

• Asynchrony Index — 1 hour
  \[(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)\]x100

Trial sites (5)

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