Automatic Adjustment for Asynchronies During Mechanical Ventilation

Not Applicable

Terminated

• Conditions: Mechanical Ventilation Complication
• Interventions: Device: Intellisync+

• Registration Number: NCT06295237
• Lead Sponsor: Hospital San Carlos, Madrid

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 (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 Timeline

• Study Start: 2024-02-15
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-06
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age >17 years
• Partial ventilatory support ("SPONT" mode) connected to Hamilton C1 model, irrespective of chronic restrictive or obstructive lung disease, categorized by RCexp (Expiratory time constant): restrictive (RCExp <0.6); obstructive (RCExp >0.9); normal (RCExp 0.6 - 0.9).
• Software version SW3.0.0 or superior and the IntelliSync+ software tool available in invasive and non-invasive ventilation.
• Presence of asyncronies in pressure and volume curves tracings of the ventilator.
• Signed informed content.

Exclusion Criteria

• Pregnant
• On extracorporeal respiratory support (ECMO or ECCO2R)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Activated automatic detection and adjustment of asynchronies	Intellisync+	Active mode of a mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.

Primary Outcome Measures

Name	Time	Method
Duration of asyncronies	two hours per study arm	duration of asyncronies expressed as percentage of time during the respective 2-hour study periods

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain