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RECRUITING
NCT05731024
NA

Closed-loop Synchronization Versus Conventional Synchronization

Sponsor: Dr. Behcet Uz Children's Hospital

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

1 Month - 18 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2023-02-06

Completion Date

2025-12-30

Last Updated

2025-03-19

Healthy Volunteers

No

Interventions

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.

Locations (5)

Aydin Obstetric and pediatrics Hospital

Aydin, Turkey (Türkiye)

Erzurum Regional Research and Training Hospital

Erzurum, Turkey (Türkiye)

Erzurum Regional Research and Training Hospital

Erzurum, Turkey (Türkiye)

Cam Sakura Research and Training Hospital

Istanbul, Turkey (Türkiye)

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, Turkey (Türkiye)