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

Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive Ventilation Patients (CHEST-SPAN) - a Randomized Cross-over Trial

This study is testing if a new automatic breathing device helps adults using noninvasive ventilation breathe better compared to standard methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Başakşehir Çam & Sakura City Hospital (other gov)
• Locations: 1 site (Izmir)
• Trial ID: NCT06357780 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old who are hospitalized in the ICU or emergency department and require noninvasive ventilation for at least two hours.

Not a fit: Patients who are pregnant, have hemodynamic instability, or are under formalized ethical decisions to withhold life support may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the effectiveness of noninvasive ventilation, leading to better respiratory support for patients with acute respiratory failure.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving patient-ventilator interactions, suggesting potential for success.

Eligibility criteria

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 this trial is running

Izmir

• 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

Conditions: Acute Respiratory Failure, Acute Respiratory Distress Syndrome, Chronic Respiratory Failure, Acute respiratory failure, noninvasive ventilation, Closed-loop, synchronization, patient ventilator asynchrony