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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Annemijn Jonkman, PhD
- Número de telefone: +3110-7035142
- E-mail: a.jonkman@erasmusmc.nl
Locais de estudo
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North Brabant
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Eindhoven, North Brabant, Holanda, 5623EJ
- Recrutamento
- Catharina Ziekenhuis Eindhoven (CZE)
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Contato:
- Ashley de Bie, PhD
- Número de telefone: +3140-2399500
- E-mail: ashley.d.bie@catharinaziekenhuis.nl
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Investigador principal:
- Ashley de Bie, PhD
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Subinvestigador:
- Thijs Rietveld, MSc
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South Holland
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Leiden, South Holland, Holanda, 2333ZA
- Ainda não está recrutando
- Leiden University Medical Center (LUMC)
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Subinvestigador:
- Thijs Rietveld, MSc
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Contato:
- Bram Schoe, PhD
- E-mail: a.schoe@lumc.nl
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Investigador principal:
- Bram Schoe, PhD
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Rotterdam, South Holland, Holanda, 3015GD
- Recrutamento
- Erasmus Medical Center (EMC)
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Contato:
- Annemijn Jonkman, PhD
- Número de telefone: +3110-7035142
- E-mail: a.jonkman@erasmusmc.nl
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Investigador principal:
- Annemijn Jonkman, PhD
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Subinvestigador:
- Thijs P Rietveld, MSc
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Asynchrony index over time (aggregated and per PVA type)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mortalidade no dia 28
Prazo: 28 dias
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Mortalidade no dia 28
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28 dias
|
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Use of sedatives (cumulative dose and type)
Prazo: 28 days
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28 days
|
|
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Mechanical ventilation settings
Prazo: 28 days
|
28 days
|
|
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Respiratory parameters
Prazo: 28 days
|
28 days
|
|
|
Hemodynamic parameters
Prazo: 28 days
|
28 days
|
|
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Relevant medication
Prazo: 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
Prazo: 28 days
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e.g.
dialysis, pacemaker, ventricular assist device, ECMO
|
28 days
|
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Gas exchange parameters
Prazo: 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
Prazo: 28 days
|
upon availability in the patient's electronic chart, e.g.
CRP, lactate
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28 days
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Sedation depth
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 90 days
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Mortality during ICU stay
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90 days
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Mortality at day 90
Prazo: 90 days
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Mortality at day 90
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90 days
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Duration of ventilation
Prazo: 28 days
|
Duration of ventilation in hours or days
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28 days
|
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Ventilator free days (at day 28)
Prazo: 28 days
|
Number of ventilator free days at day 28
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28 days
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Ventilator free days (at day 90)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 28 days
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Length of ICU stay, measured in days
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28 days
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Complications
Prazo: 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
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MEC-2025-0353
- EMCLSH24018 (Número de outro subsídio/financiamento: Health~Holland)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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- PROTOCOLO DE ESTUDO
- ANALYTIC_CODE
- CSR
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