NCT06295237

Automatic Adjustment for Asynchronies During Mechanical Ventilation

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: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• Mechanical Ventilation Complication

Interventions

Type	Name	Description
DEVICE	Intellisync+	mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.

Timeline

• Start date: 2024-02-15
• Primary completion: 2024-12-15
• Completion: 2024-12-15
• First posted: 2024-03-06
• Last updated: 2025-03-07

Locations

1 site across 1 country: Spain