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Automatic Adjustment for Asynchronies During Mechanical Ventilation — i-Sync  

Mechanical Ventilation Complication Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The prevalence and time course of asynchronies will be evaluated in subjects under invasive (n=40) or non-invasive (n=40) 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. ;

Study Design

Related Conditions & MeSH terms

  • Mechanical Ventilation Complication
Clinical Trial Details
NCT number NCT06295237
Study type Interventional
Source Hospital San Carlos, Madrid
Contact Miguel Sanchez-Garcia, MD
Phone +34658762739
Email miguelsanchez.hcsc@gmail.com
Status Recruiting
Phase N/A
Start date February 15, 2024
Completion date July 1, 2025
View Details
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