Comparing closed-loop synchronization to conventional synchronization in noninvasive ventilation for breathing patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentric prospective randomized cross-over study evaluates the effectiveness of a closed-loop synchronization device compared to conventional synchronization methods in adult patients receiving noninvasive ventilation. The study involves monitoring patient-ventilator asynchrony (PVA) using both clinician-adjusted and standard pre-set values over specified time intervals. The IntelliSync+ software will be utilized to analyze waveform signals in real-time, allowing for immediate adjustments based on patient efforts. The goal is to determine if automatic synchronization improves patient outcomes without altering routine treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Dr.Suat Seren Chest Diseasees Hospital
  Izmir, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Ramazan Guven, Associate professor — Basaksehir Cam Sakura city Hospital, Istanbul
• Study coordinator: Ramazan Guven, Associate professor
• Email: drramazanguven@gmail.com
• Phone: 05324935995

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.