Mechanical Ventilation Complication
Conditions
Keywords
Asyncronies, Mechanical ventilation, Automatic detection and adjustment
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.
Interventions
DEVICEIntellisync+
mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.
Sponsors
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Hospital San Carlos, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Anonymized evaluation
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* Pregnant * On extracorporeal respiratory support (ECMO or ECCO2R)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of asyncronies | two hours per study arm | duration of asyncronies expressed as percentage of time during the respective 2-hour study periods |
Countries
Spain
Outcome results
None listed