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

Launched by BAŞAKŞEHIR ÇAM & SAKURA CITY HOSPITAL · Apr 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method of helping patients with breathing difficulties, particularly those suffering from conditions like acute respiratory failure or chronic respiratory failure. The researchers want to see if a device that automatically adjusts to the patient’s breathing is better than traditional methods that rely on manual settings. Patients in the study will be monitored while receiving noninvasive ventilation (a way to help them breathe without needing a breathing tube), and their breathing patterns will be recorded to compare how well each method works.

To participate, individuals must be adults over 18 years old who are currently in the intensive care unit or emergency department and need help with breathing for at least two hours. They should be able to give consent or have a family member provide consent for them if they are unable to do so. Participants will have their breathing monitored using advanced technology that tracks their efforts in real-time, allowing researchers to gather important data on how effectively each method supports their breathing. It’s important to note that those who are very unstable or require specific medical attention may not be eligible for this study.

Gender

ALL

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