Automatic Adjustment for Asynchronies During Mechanical Ventilation

NCT06295237 | Terminated

• 1 other identifier: i-Sync
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication

Keywords

Asyncronies; Mechanical ventilation; Automatic detection and adjustment

Outcome Measures

Primary Outcomes (1)

• Duration of asyncronies

  duration of asyncronies expressed as percentage of time during the respective 2-hour study periods

  two hours per study arm

Study Arms (2)

Standard of Care

NO INTERVENTION

Optimized ventilator settings to control and reduce the number of asynchronies

Activated automatic detection and adjustment of asynchronies

ACTIVE COMPARATOR

Active mode of a mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.

Device: Intellisync+

Interventions

Intellisync+ DEVICE

mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.

Activated automatic detection and adjustment of asynchronies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Study Officials

• Miguel Sanchez-Garcia, MD

  Hospial Clinico San Carlos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Anonymized evaluation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Critical Care Department

Model Details: Two 2-hour periods: 1) "off mode" consisting of a control period with optimized ventilator parameters and 2) "on mode" with an active automated detection and adjustment for asynchronies. The starting first period is randomized.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: February 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

ES (1)