Automatic Adjustment for Asynchronies During Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2024-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Patient-ventilator Synchronisation Study for Intensive Care Unit Patients

NCT03787173

Acute Respiratory Failure

COMPLETED NA

Asynchronies During Mechanical Ventilation

NCT03451461

Mechanical Ventilation Complication

COMPLETED

Evaluation of an Informative Intervention to the ICU Team About the Presence of Asynchronies in Mechanically Ventilated Patients: Effect Over Incidence Reduction

NCT02714751

Asynchronies

COMPLETED NA

Intellivent Versus Conventional Ventilation

NCT01577667

Respiratory Failure Self Efficacy

COMPLETED PHASE3

Patient-Ventilator Interactions in Chronic Obstructive Pulmonary Diseases (COPD) Under Non-Invasive Ventilation

NCT01180439

Chronic Obstructive Pulmonary Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Ventilation Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Anonymized evaluation

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of Care

Optimized ventilator settings to control and reduce the number of asynchronies

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Intellisync+

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intellisync+

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.