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Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients

RecruitingNAAges 18 Years - anyAllBaşakşehir Çam & Sakura City Hospital
NCT06357780 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study is a multicentric prospective randomised cross-over study. It evaluates the compatibility of patients with the device without altering the routine treatment applied. During this evaluation, either the clinician-adjusted values on the device or the standard pre-set values are used to obtain hourly and 30-minute PVA (Patient Ventilator Asynchrony) recordings. These recordings will be analysed offline to identify the settings used and to compare the hourly and 30-minute PVA (Patient Ventilator Asynchrony) values when synchronisation is automatically set. The relationships and differences between these values will be analysed. For this purpose, the IntelliSync+ option, already available on the device, will be used. This software continuously analyses waveform signals at least a hundred times per second. This allows for the immediate detection of patient efforts and the initiation o

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients older than 18 years of age * Hospitalized at the ICU or emergency department with the intention of treatment with Noninvasive ventilation at least for the upcoming 2 hours with spontaneous breathing activity * Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation Exclusion Criteria: * Formalized ethical decision to withhold or withdraw life support * Patient included in another interventional research study under consent * Patient already enrolled in the present study in a previous episode of respiratory failure * Pregnant woman * Patients deemed at high risk for the need of transportation from an intensive care unit or emergency department to another ward, diagnostic unit or any other hospital * Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h * Not being able to obtain reference waveforms due to technical or medical problems * Vulnerable population * Increase or decrease of ventilatory support either in pressures, fraction of inspired oxygen or mode of ventilation during study period
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What it tests

  • close-loop synchronization controller with spontaneous mode
  • Conventional
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Where

1 site
Dr.Suat Seren Chest Diseasees Hospital
Izmir, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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