Patient-ventilator asynchrony during assisted mechanical ventilation.
Arnaud W Thille, Pablo Rodriguez, Belen Cabello...
https://pubmed.ncbi.nlm.nih.gov/16896854Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06357780
Closed-loop Synchronization Versus Conventional Synchronization in Spontaneously Breathing Adult Noninvasive Ventilation Patients (CHEST-SPAN) - a Randomized Cross-over Trial
Led by Başakşehir Çam & Sakura City Hospital · Updated on 2025-03-26
38
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized cross-over study to evaluate how well patients tolerate a new device feature called IntelliSync+ compared to traditional settings during noninvasive ventilation. The study focuses on adults with acute or chronic respiratory failure who are spontaneously breathing and receiving noninvasive ventilation. The goal is to compare patient ventilator asynchrony (PVA) using automated versus manual synchronization methods to better understand their differences and relationships. Participants will experience two different 30-minute periods of ventilation: one where the pressure support is automatically adjusted based on real-time waveform analysis using the IntelliSync+ software, and another where synchronization is manually set by the clinician. IntelliSync+ continuously analyzes breathing signals to detect patient efforts and trigger breaths more precisely. The study compares these two methods to assess synchronization quality during noninvasive ventilation. During the study, patients will be monitored closely while researchers collect and analyze hourly and 30-minute recordings of patient ventilator asynchrony. Various statistical tests will be used to evaluate the data, including measures of asynchrony indices and dyspnea scales. Participants will be observed during their ICU or emergency care stay while receiving routine treatment, and all findings will be reported by the research team. The total participation involves a short intervention period with detailed waveform analysis and data collection.
CONDITIONS
Brief Title
Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients older than 18 years of age
- Hospitalized in ICU or emergency department
- Planned treatment with noninvasive ventilation with spontaneous breathing for at least 2 hours
- Signed informed consent by patient or relative if patient cannot consent
You will not qualify if you...
- Ethical decision to withhold or withdraw life support
- Participation in another interventional research study
- Previous enrollment in this study for a prior respiratory failure episode
- Pregnant women
- High risk for transport from ICU or emergency department
- Hemodynamic instability requiring continuous epinephrine or norepinephrine infusion above 1 mg/h
- Inability to obtain reference waveforms due to technical or medical issues
- Vulnerable populations
- Change in ventilatory support settings during study period (pressure, oxygen fraction, or mode)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 1 hour
Participants receive two different 30-minute periods of noninvasive ventilation synchronization: one with a closed-loop synchronization controller and one with conventional manual synchronization, in a randomized order.
1 treatment visit (in-person)
Trial Site Locations
Total: 1 location
1
Dr.Suat Seren Chest Diseasees Hospital
Izmir, Turkey (Türkiye), 35230
Actively Recruiting
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Research Team
R
Ramazan Guven, Associate professor
T
Tuba Dogan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Monitoring the patient-ventilator asynchrony during non-invasive ventilation.
Federico Longhini, Andrea Bruni, Eugenio Garofalo...
https://pubmed.ncbi.nlm.nih.gov/36743668Relationships between double cycling and inspiratory effort with diaphragm thickness during the early phase of mechanical ventilation: A prospective observational study.
Taiga Itagaki, Yusuke Akimoto, Yuki Nakano...
https://pubmed.ncbi.nlm.nih.gov/35976965Factors affecting abnormal triggering with non-invasive ventilators: A before-and-after study.
Zhaoning Xu, Dongqin Sheng, Kefan Jiao...
https://pubmed.ncbi.nlm.nih.gov/35642081Timing of inspiratory muscle activity detected from airway pressure and flow during pressure support ventilation: the waveform method.
Francesco Mojoli, Marco Pozzi, Anita Orlando...
https://pubmed.ncbi.nlm.nih.gov/35094707