Clinical trial NCT06295237: Automatic Adjustment for Asynchronies During Mechanical Ventilation
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mechanical Ventilation Complication
Keywords: Asyncronies
Mechanical ventilation
Automatic detection and adjustment
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
First posted: 2024-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Duration of asyncronies
timeFrame: two hours per study arm
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Hospial Clinico San Carlos
name: Miguel Sanchez-Garcia, MD
role: STUDY_CHAIR
References: