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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Duration of asyncronies
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Anonymized evaluation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •On extracorporeal respiratory support (ECMO or ECCO2R)
Arms & Interventions
Standard of Care
Optimized ventilator settings to control and reduce the number of asynchronies
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.
Intervention: Intellisync+ (Device)
Outcomes
Primary Outcomes
Duration of asyncronies
Time Frame: two hours per study arm
duration of asyncronies expressed as percentage of time during the respective 2-hour study periods
Secondary Outcomes
No secondary outcomes reported
Investigators
Miguel Sanchez Garcia
Director Critical Care Department
Hospital San Carlos, Madrid