Automatic Adjustment for Asynchronies During Mechanical Ventilation

Mechanical Ventilation Complication Clinical Trial

— i-Sync  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT06295237
• Other study ID #: i-Sync
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: March 2024
• Source: Hospital San Carlos, Madrid
• Contact: Miguel Sanchez-Garcia, MD
• Phone: +34658762739
• Email: miguelsanchez.hcsc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• Intellisync+
mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of asyncronies	duration of asyncronies expressed as percentage of time during the respective 2-hour study periods	two hours per study arm