NCT06357780 Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients
| NCT ID | NCT06357780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Başakşehir Çam & Sakura City Hospital |
| Condition | Acute Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2025-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 38 participants in total. It began in 2024-04-08 with a primary completion date of 2025-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 of inspiration and expiration in real time, thereby replacing traditional trigger settings for inspiration and expiration. If the patient is already synchronised with this option, it will then be possible to switch to traditional synchronisation settings for comparison. Statistical analyses will be conducted using SPSS 24.0, JASP (Just Another Statistical Programme), Jamovi ( fork of JASP), or R software. Initially, all numerical and categorical data will be evaluated using descriptive statistical methods. The distributions of numerical variables will be examined using visual (histograms and probability plots) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Mean/SD (standard deviation) or median/interquartile range (IQR) will be used as measures of distribution. For comparing numerical data that follows a normal distribution, the Student-t test will be used, and for non-normally distributed data, the Mann-Whitney U or Wilcoxon signed-rank tests will be employed. PVA (Patient Ventilator Asynchrony) values will be statistically compared. For the analysis of categorical data, the Chi-Square test will be applied. Bayesian analysis may also be used as necessary during the writing of the study. The results obtained will be interpreted and reported by the researchers. Results with a "p" value below 0.05 will be considered statistically significant.
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
Contact & Investigator
Ramazan Guven, Associate professor
PRINCIPAL INVESTIGATOR
Basaksehir Cam Sakura city Hospital, Istanbul
Frequently Asked Questions
Who can join the NCT06357780 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06357780 currently recruiting?
Yes, NCT06357780 is actively recruiting participants. Contact the research team at drramazanguven@gmail.com for enrollment information.
Where is the NCT06357780 trial being conducted?
This trial is being conducted at Izmir, Turkey (Türkiye).
Who is sponsoring the NCT06357780 clinical trial?
NCT06357780 is sponsored by Başakşehir Çam & Sakura City Hospital. The principal investigator is Ramazan Guven, Associate professor at Basaksehir Cam Sakura city Hospital, Istanbul. The trial plans to enroll 38 participants.