Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Close-loop synchronization controller | Experimental | 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 | Active Comparator | 30 minutes period where the synchronization of pressure support of patient effort during NIV mode will be manually set. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| close-loop synchronization controller with spontaneous mode | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Asynchrony Index | [(detectable asynchronies )/(total number of breaths + ineffective efforts)]x100 | 30 minutes |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramazan Guven, Associate professor | Contact | 05324935995 | drramazanguven@gmail.com | |
| Tuba Dogan, MD | Contact | dr.tubadogan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ramazan Guven, Associate professor | Basaksehir Cam Sakura city Hospital, Istanbul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr.Suat Seren Chest Diseasees Hospital | Recruiting | Izmir | 35230 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16896854 | Background | 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. | |
| 36743668 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional | Other | 30 minutes period where the synchronization of pressure support of patient effort during NIV mode will be manually set. |
|
| 30 minutes |
| Dyspnea Scale | Patient subjective dyspnea scale | 30 minutes |
| 35976965 | Background | 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. |
| 35642081 | Background | 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. |
| 35094707 | Background | 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. |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000097742 | Patient-Ventilator Asynchrony |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012131 | Respiratory Insufficiency |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
Not provided
Not provided