Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357780
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-05
Brief Title:
Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive ventilationPatients
Sponsor:
Başakşehir Çam Sakura City Hospital
Organization:
Başakşehir Çam Sakura City Hospital
Study Overview
Official Title:
Closed-loop syncHronization vErsuS convenTional Synchronization in sPontaneously Breathing Adult Nonivasive Ventilation Patients CHEST-SPAN - a Randomized Cross-over Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHESTSPAN
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 240 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-SmirnovShapiro-Wilk tests MeanSD standard deviation or medianinterquartile 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 005 will be considered statistically significant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None