Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295237
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-28
Brief Title:
Automatic Adjustment for Asynchronies During Mechanical Ventilation
Sponsor:
Hospital San Carlos Madrid
Organization:
Hospital San Carlos Madrid
Study Overview
Official Title:
Comparison of the Prevalence of Asynchronies During Mechanical Ventilation With Manual Versus Automatic Adjustment Ventilator Settings Using the INTELLISYNC HAMILTON Tool A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
i-Sync
Brief Summary:
Asynchronies between the patient and the artificial ventilator are a frequent problem They may cause altered sleep ventilator-induced lung injury prolong length of ICU stay cause neuro-psycologic complications and increase mortality Although reducing their incidence through ventilator setting adjustments is possible they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters Ventilator systems may detect and automatically adjust parameters of mechanical ventilation This would avoid delays in detection and adjustment if the intensivist is not immediately available The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software
Detailed Description:
The prevalence and time course of asynchronies will be evaluated in subjects under invasive n40 or non-invasive n40 mechanical ventilation Intensivist-optimized ventilator settings will be compared to a software tool Hamilton ventilators Intellisync in its capacity to control and adjust the triggering and cycling by analysis of the ventilator curves
The outcome variable is the percentage of the duration of asynchronies during the two 2-hour study periods
This pilot study has a prospective randomized cross-over design The order of the 2 study periods will be randomized to either start with control with manual adjustment or automated adjustment with Intellisync
The total sample size is 80 subjects 40 receiving invasive mechanical ventilation and 40 on non-invasive mechanical ventilation
The outcome variable is the percentage of the duration of asynchronies during the two 2-hour study periods
This pilot study has a prospective randomized cross-over design The order of the 2 study periods will be randomized to either start with control with manual adjustment or automated adjustment with Intellisync
The total sample size is 80 subjects 40 receiving invasive mechanical ventilation and 40 on non-invasive mechanical ventilation
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