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

Official title

Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive Ventilation Patients (CHEST-SPAN) - a Randomized Cross-over Trial

Overview

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.

Interventions

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

Primary outcome measures

• Asynchrony Index [Time frame: 30 minutes]

Secondary outcome measures (3)

• Major Asynchrony index [Time frame: 30 minutes]
• Minor Asynchrony index [Time frame: 30 minutes]
• Dyspnea Scale [Time frame: 30 minutes]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Dr.Suat Seren Chest Diseasees Hospital — Izmir

Publications

• Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1. PMID 16896854
• Longhini F, Bruni A, Garofalo E, Tutino S, Vetrugno L, Navalesi P, De Robertis E, Cammarota G. Monitoring the patient-ventilator asynchrony during non-invasive ventilation. Front Med (Lausanne). 2023 Jan 19;9:1119924. doi: 10.3389/fmed.2022.1119924. eCollection 2022. PMID 36743668
• Itagaki T, Akimoto Y, Nakano Y, Ueno Y, Ishihara M, Tane N, Tsunano Y, Oto J. Relationships between double cycling and inspiratory effort with diaphragm thickness during the early phase of mechanical ventilation: A prospective observational study. PLoS One. 2022 Aug 17;17(8):e0273173. doi: 10.1371/journal.pone.0273173. eCollection 2022. PMID 35976965
• Xu Z, Sheng D, Jiao K, Zhang C, Hao J, Ma D. Factors affecting abnormal triggering with non-invasive ventilators: A before-and-after study. Clin Respir J. 2022 Jun;16(6):450-459. doi: 10.1111/crj.13497. Epub 2022 May 31. PMID 35642081
• Mojoli F, Pozzi M, Orlando A, Bianchi IM, Arisi E, Iotti GA, Braschi A, Brochard L. Timing of inspiratory muscle activity detected from airway pressure and flow during pressure support ventilation: the waveform method. Crit Care. 2022 Jan 30;26(1):32. doi: 10.1186/s13054-022-03895-4. PMID 35094707

Identifiers

NCT: NCT06357780 · 240396837

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗