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Closed-loop Synchronization Versus Conventional Synchronization

NCT05731024 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-19

No results posted yet for this 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).

Conditions

  • Acute Respiratory Failure
  • Pediatric Respiratory Distress Syndrome

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.

Sponsors & Collaborators

  • Hamilton Medical AG

    collaborator INDUSTRY

  • Dr. Behcet Uz Children's Hospital

    lead OTHER

Principal Investigators

  • Hasan Agin, Professor · Behcet Uz Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2025-11-30
Completion
2025-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05731024 on ClinicalTrials.gov