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

Başakşehir Çam & Sakura City Hospital

Status

Enrolling

Conditions

Chronic Respiratory Failure

Acute Respiratory Distress Syndrome

Acute Respiratory Failure

Treatments

Other: Conventional

Other: close-loop synchronization controller with spontaneous mode

Study type

Interventional

Funder types

Other

Identifiers

NCT06357780

240396837

Details and patient eligibility

About

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.

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

38 participants in 2 patient groups

Close-loop synchronization controller

Experimental group

Description:

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.

Treatment:

Other: close-loop synchronization controller with spontaneous mode

Conventional

Active Comparator group

Description:

30 minutes period where the synchronization of pressure support of patient effort during NIV mode will be manually set.

Treatment:

Other: Conventional