The goal of this observational study is to unravel the occurence, impact and relations of Patient-Ventilator Aynchrony (PVA) in mechanically ventilated patients. The main questions it aims to answer are: * How often does PVA occur? * What are relations between clinical characteristics and PVA occurence? * What are relations between PVA occurence and patient outcomes? All questions will be assessed using data collected during the whole course of mechanical ventilation. Mechanically ventilated patients' medical data will be re-used. PVAs will be automatically classified on ventilator waveform data, using validated Deep Breath software.
Many ventilated patients show excessive breathing efforts and abnormal, irregular breathing. This patient-ventilator asynchrony (PVA) is associated with serious discomfort, lung injury, sleep disruption and higher mortality. PVA exists in many forms and is reported in 10-90% of patients, but identifying and resolving it is challenging, even for expert clinicians. Hence, PVA prevalence and impact is likely highly underestimated, and the direct causal link with worse outcomes is inconclusive. PVAs should be better dettected, understood and resovled to optimize the individual patient's treatment. In a previous study, the investigators validated an AI-based algorithm capable of reliable PVA detection (Deep Breath software). In this study, the investigators will apply this algorithm to the collected ventilator waveform data (offline processing), in order to reliably assess PVA occurrence, and its relation with clinical outcomes and patient characteristics in current clinical care. Data of minimally 110 patients collected over the whole course of mechanical ventilation will be assessed. Patients will be included in three ICUs to promote generalizability. The primary outcome will be the asynchrony index (in total and per PVA type) over time. Secondary outcomes will include, but are not limited to: clinical characteristics (e.g. respiratory and hemodynamic parameters, sedation), (ICU) mortality, ventilator free days at day 28 and 90, duration of ventilation, weaning success and reintubation rate.
Study Type
OBSERVATIONAL
Enrollment
110
Patients will receive standard care, without an intervention. Data will be captured as part of standard care and analyzed for PVAs retrospectively, using dedicated offline software.
Catharina Ziekenhuis Eindhoven (CZE)
Eindhoven, North Brabant, Netherlands
Leiden University Medical Center (LUMC)
Leiden, South Holland, Netherlands
Erasmus Medical Center (EMC)
Rotterdam, South Holland, Netherlands
Asynchrony index over time (aggregated and per PVA type)
Measure of how much asynchrony occurs and at what time. This measure will be calculated for all PVA types together, as well as per PVA type. The investigators calculate this over time, to see when asynchrony occurs, as well as in total, to get a global PVA prevalence measure (over the whole duration of ventilation).
Time frame: 28 days
Use of sedatives (cumulative dose and type)
Time frame: 28 days
Mechanical ventilation settings
Time frame: 28 days
Respiratory parameters
Time frame: 28 days
Hemodynamic parameters
Time frame: 28 days
Relevant medication
e.g. vasoactive agents, delirium related medication, analgesics
Time frame: 28 days
Use of assist devices
e.g. dialysis, pacemaker, ventricular assist device, ECMO
Time frame: 28 days
Gas exchange parameters
e.g. P/F ratio, PaO2, PaCO2, pH, bicarbonate
Time frame: 28 days
Blood inflammatory biomarkers
upon availability in the patient's electronic chart, e.g. CRP, lactate
Time frame: 28 days
Sedation depth
Richmond Agitation-Sedation Scale (RASS-score). This score ranges from -5 to +4, where a more positive score indicates more agitation.
Time frame: 28 days
Reported delirium
Reported delirium, observed via the Delirium Observation Screening (DOS), or the Intensive Care Delirium Screening Checklist (ICDSC), depending on the standard of care of the participating center. The DOS ranges from 0-13, with a score ≥3 indicating delirium. The ICDSC ranges from 0-8, with 0-3 indicating absence of delirium and a score of ≥4 inidicating delirium.
Time frame: 28 days
Illness severity score (SOFA-score)
SOFA-score. This score ranges from 0-24, with increasing scores reflecting more abnormal physiology and biochemistry or an increasing degree of intervention.
Time frame: 28 days
ICU mortality
Mortality during ICU stay
Time frame: 90 days
Mortality at day 28
Mortality at day 28
Time frame: 28 days
Mortality at day 90
Mortality at day 90
Time frame: 90 days
Duration of ventilation
Duration of ventilation in hours or days
Time frame: 28 days
Ventilator free days (at day 28)
Number of ventilator free days at day 28
Time frame: 28 days
Ventilator free days (at day 90)
Number of ventilator free days at day 90
Time frame: 90 days
Reintubation rate
Number of times reintubation occured, reported as % of patients needing reintubation.
Time frame: 28 days
Weaning success
Weaning success rate (%), defined as seven consecutive days without ventilator support
Time frame: 28 days
ICU length of stay
Length of ICU stay, measured in days
Time frame: 28 days
Complications
Complications (e.g. ventilator associated pneumonia and ICU acquired weakness) as reported in the patient file.
Time frame: 28 days
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