Automatic Adjustment for Asynchronies During Mechanical Ventilation (i-Sync)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Device: Intellisync+

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miguel Sanchez-Garcia, MD; Phone Number: +34658762739; Email: miguelsanchez.hcsc@gmail.com
• Study Contact Backup: Name: Fernando Suarez Sipmann, MD; Phone Number: +34 665 052 460; Email: fsuarez@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
    • Contact: Miguel Sanchez-Garcia, MD; Phone Number: +34658762739; Email: miguelsanchez.hcsc@gmail.com
    • Contact: Paloma Gonzalez-Arenas, MD; Phone Number: +34 670 57 66 45; Email: pgarenas@gmail.com
    • Sub-Investigator: David Janeiro Lumbreras, MD
    • Principal Investigator: Fernando Suarez-Sipmann, MD
    • Sub-Investigator: José Antonio Sánchez-Giralt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Optimized ventilator settings to control and reduce the number of asynchronies
Active Comparator: Activated automatic detection and adjustment of asynchronies; Active mode of a mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.	Device: Intellisync+; mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of asyncronies	duration of asyncronies expressed as percentage of time during the respective 2-hour study periods	two hours per study arm

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid
• Collaborators: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Investigators: Study Chair: Miguel Sanchez-Garcia, MD, Hospial Clinico San Carlos

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Asyncronies; Automatic detection and adjustment
• Other Study ID Numbers: i-Sync

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No