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

Not Applicable

Recruiting

• Conditions: Acute Respiratory Failure; Acute Respiratory Distress Syndrome; Chronic Respiratory Failure
• Interventions: Other: close-loop synchronization controller with spontaneous mode; Other: Conventional

• Registration Number: NCT06357780
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-05
• Study Start: 2024-04-08
• Study First Posted: 2024-04-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Close-loop synchronization controller	close-loop synchronization controller with spontaneous mode	30 minutes period where the pressure support of spontaneous effort will be automatically titrated based on pressure and flow waveform analysis obtained from the patient during NIV mode.
Conventional	Conventional	30 minutes period where the synchronization of pressure support of patient effort during NIV mode will be manually set.

Primary Outcome Measures

Name	Time	Method
Asynchrony Index	30 minutes	\[(detectable asynchronies )/(total number of breaths + ineffective efforts)\]x100

Secondary Outcome Measures

Name	Time	Method
Minor Asynchrony index	30 minutes	\[(minor asynchronies)/(total number of breaths + ineffective efforts)\]x100
Major Asynchrony index	30 minutes	\[(major asynchronies)/(total number of breaths + ineffective efforts)\]x100
Dyspnea Scale	30 minutes	Patient subjective dyspnea scale

Trial Locations

Locations (1)

Dr.Suat Seren Chest Diseasees Hospital; 🇹🇷 Izmir, Turkey