NCT05731024

Closed-loop Synchronization Versus Conventional Synchronization

Protocol for Comparing Closed-loop syncHronization vErsuS convenTional Synchronization In sPontaneously Breathing Pediatric Patients (CHESTSIPP) - a Randomized Cross-over Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Dr. Behcet Uz Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Respiratory Failure
• Pediatric Respiratory Distress Syndrome

Interventions

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

Timeline

• Start date: 2023-02-06
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2023-02-16
• Last updated: 2025-03-19

Locations

5 sites across 1 country: Turkey (Türkiye)