Patient-Ventilator Asynchrony: Occurence and Clinical Impact in Usual Care (PVA-detection)
Unraveling the Clinical Impact of Patient-Ventilator Asynchrony in Usual Care
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Annemijn Jonkman, PhD
- Número de teléfono: +3110-7035142
- Correo electrónico: a.jonkman@erasmusmc.nl
Ubicaciones de estudio
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North Brabant
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Eindhoven, North Brabant, Países Bajos, 5623EJ
- Reclutamiento
- Catharina Ziekenhuis Eindhoven (CZE)
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Contacto:
- Ashley de Bie, PhD
- Número de teléfono: +3140-2399500
- Correo electrónico: ashley.d.bie@catharinaziekenhuis.nl
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Investigador principal:
- Ashley de Bie, PhD
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Sub-Investigador:
- Thijs Rietveld, MSc
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South Holland
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Leiden, South Holland, Países Bajos, 2333ZA
- Aún no reclutando
- Leiden University Medical Center (LUMC)
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Sub-Investigador:
- Thijs Rietveld, MSc
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Contacto:
- Bram Schoe, PhD
- Correo electrónico: a.schoe@lumc.nl
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Investigador principal:
- Bram Schoe, PhD
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Rotterdam, South Holland, Países Bajos, 3015GD
- Reclutamiento
- Erasmus Medical Center (EMC)
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Contacto:
- Annemijn Jonkman, PhD
- Número de teléfono: +3110-7035142
- Correo electrónico: a.jonkman@erasmusmc.nl
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Investigador principal:
- Annemijn Jonkman, PhD
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Sub-Investigador:
- Thijs P Rietveld, MSc
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age > 18 years old.
- Recordings available of ventilator waveforms synchronized with the patient's electronic health record during invasive mechanical ventilation.
- Duration of mechanical ventilation of at least 24 hours.
Exclusion Criteria:
- (Previous) registered objection of patient and/or relatives to re-use clinical data for research purposes
- No consent for re-use of data for research
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Adult patients admitted to the ICU that receive invasive mechanical ventilation
Patients need to be >18 years old, receive mechanical ventilation for at least 24 hours and have recordings available of ventilator waveforms, synchronized with the patient's electronic health record, during invasive mechanical ventilation.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Asynchrony index over time (aggregated and per PVA type)
Periodo de tiempo: 28 days
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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).
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28 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mortalidad en el día 28
Periodo de tiempo: 28 días
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Mortalidad en el día 28
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28 días
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Use of sedatives (cumulative dose and type)
Periodo de tiempo: 28 days
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28 days
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Mechanical ventilation settings
Periodo de tiempo: 28 days
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28 days
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Respiratory parameters
Periodo de tiempo: 28 days
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28 days
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Hemodynamic parameters
Periodo de tiempo: 28 days
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28 days
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Relevant medication
Periodo de tiempo: 28 days
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e.g.
vasoactive agents, delirium related medication, analgesics
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28 days
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Use of assist devices
Periodo de tiempo: 28 days
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e.g.
dialysis, pacemaker, ventricular assist device, ECMO
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28 days
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Gas exchange parameters
Periodo de tiempo: 28 days
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e.g.
P/F ratio, PaO2, PaCO2, pH, bicarbonate
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28 days
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Blood inflammatory biomarkers
Periodo de tiempo: 28 days
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upon availability in the patient's electronic chart, e.g.
CRP, lactate
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28 days
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Sedation depth
Periodo de tiempo: 28 days
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Richmond Agitation-Sedation Scale (RASS-score).
This score ranges from -5 to +4, where a more positive score indicates more agitation.
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28 days
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Reported delirium
Periodo de tiempo: 28 days
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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.
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28 days
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Illness severity score (SOFA-score)
Periodo de tiempo: 28 days
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SOFA-score.
This score ranges from 0-24, with increasing scores reflecting more abnormal physiology and biochemistry or an increasing degree of intervention.
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28 days
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ICU mortality
Periodo de tiempo: 90 days
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Mortality during ICU stay
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90 days
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Mortality at day 90
Periodo de tiempo: 90 days
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Mortality at day 90
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90 days
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Duration of ventilation
Periodo de tiempo: 28 days
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Duration of ventilation in hours or days
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28 days
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Ventilator free days (at day 28)
Periodo de tiempo: 28 days
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Number of ventilator free days at day 28
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28 days
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Ventilator free days (at day 90)
Periodo de tiempo: 90 days
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Number of ventilator free days at day 90
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90 days
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Reintubation rate
Periodo de tiempo: 28 days
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Number of times reintubation occured, reported as % of patients needing reintubation.
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28 days
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Weaning success
Periodo de tiempo: 28 days
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Weaning success rate (%), defined as seven consecutive days without ventilator support
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28 days
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ICU length of stay
Periodo de tiempo: 28 days
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Length of ICU stay, measured in days
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28 days
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Complications
Periodo de tiempo: 28 days
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Complications (e.g.
ventilator associated pneumonia and ICU acquired weakness) as reported in the patient file.
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28 days
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MEC-2025-0353
- EMCLSH24018 (Otro número de subvención/financiamiento: Health~Holland)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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