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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome; Chronic Respiratory Failure; Acute Respiratory Failure
• Intervention / Treatment: Other: Conventional; Other: close-loop synchronization controller with spontaneous mode

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ramazan Guven, Associate professor; Phone Number: 05324935995; Email: drramazanguven@gmail.com
• Study Contact Backup: Name: Tuba Dogan, MD; Email: dr.tubadogan@hotmail.com

Study Locations

• Turkey
  • Izmir, Turkey, 35230
    • Recruiting
    • Dr.Suat Seren Chest Diseasees Hospital
    • Contact: Cenk Kirakli, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Close-loop synchronization controller; 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: 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.
Active Comparator: Conventional; 30 minutes period where the synchronization of pressure support of patient effort during NIV mode will be manually set.	Other: Conventional; 30 minutes period where the synchronization of pressure support of patient effort during NIV mode will be manually set.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asynchrony Index	[(detectable asynchronies )/(total number of breaths + ineffective efforts)]x100	30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital
• Investigators: Principal Investigator: Ramazan Guven, Associate professor, Basaksehir Cam Sakura city Hospital, Istanbul

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: noninvasive ventilation; Closed-loop; synchronization; patient ventilator asynchrony; Acute respiratory failure (ARF)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury
• Other Study ID Numbers: 240396837

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No