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Patient-Ventilator Asynchrony: Occurence and Clinical Impact in Usual Care (PVA-detection)

11. august 2026 oppdatert av: Annemijn Jonkman, Erasmus Medical Center

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

110

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Nederland
    • North Brabant
      • Eindhoven, North Brabant, Nederland, 5623EJ
        • Rekruttering
        • Catharina Ziekenhuis Eindhoven (CZE)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ashley de Bie, PhD
        • Underetterforsker:
          • Thijs Rietveld, MSc
    • South Holland
      • Leiden, South Holland, Nederland, 2333ZA
        • Har ikke rekruttert ennå
        • Leiden University Medical Center (LUMC)
        • Underetterforsker:
          • Thijs Rietveld, MSc
        • Ta kontakt med:
        • Hovedetterforsker:
          • Bram Schoe, PhD
      • Rotterdam, South Holland, Nederland, 3015GD
        • Rekruttering
        • Erasmus Medical Center (EMC)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Annemijn Jonkman, PhD
        • Underetterforsker:
          • Thijs P Rietveld, MSc

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Adult patients admitted to the ICU that receive invasive mechanical ventilation.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: PVA classification software
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Asynchrony index over time (aggregated and per PVA type)
Tidsramme: 28 days
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).
28 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dødelighet på dag 28
Tidsramme: 28 dager
Dødelighet på dag 28
28 dager
Use of sedatives (cumulative dose and type)
Tidsramme: 28 days
28 days
Mechanical ventilation settings
Tidsramme: 28 days
28 days
Respiratory parameters
Tidsramme: 28 days
28 days
Hemodynamic parameters
Tidsramme: 28 days
28 days
Relevant medication
Tidsramme: 28 days
e.g. vasoactive agents, delirium related medication, analgesics
28 days
Use of assist devices
Tidsramme: 28 days
e.g. dialysis, pacemaker, ventricular assist device, ECMO
28 days
Gas exchange parameters
Tidsramme: 28 days
e.g. P/F ratio, PaO2, PaCO2, pH, bicarbonate
28 days
Blood inflammatory biomarkers
Tidsramme: 28 days
upon availability in the patient's electronic chart, e.g. CRP, lactate
28 days
Sedation depth
Tidsramme: 28 days
Richmond Agitation-Sedation Scale (RASS-score). This score ranges from -5 to +4, where a more positive score indicates more agitation.
28 days
Reported delirium
Tidsramme: 28 days
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.
28 days
Illness severity score (SOFA-score)
Tidsramme: 28 days
SOFA-score. This score ranges from 0-24, with increasing scores reflecting more abnormal physiology and biochemistry or an increasing degree of intervention.
28 days
ICU mortality
Tidsramme: 90 days
Mortality during ICU stay
90 days
Mortality at day 90
Tidsramme: 90 days
Mortality at day 90
90 days
Duration of ventilation
Tidsramme: 28 days
Duration of ventilation in hours or days
28 days
Ventilator free days (at day 28)
Tidsramme: 28 days
Number of ventilator free days at day 28
28 days
Ventilator free days (at day 90)
Tidsramme: 90 days
Number of ventilator free days at day 90
90 days
Reintubation rate
Tidsramme: 28 days
Number of times reintubation occured, reported as % of patients needing reintubation.
28 days
Weaning success
Tidsramme: 28 days
Weaning success rate (%), defined as seven consecutive days without ventilator support
28 days
ICU length of stay
Tidsramme: 28 days
Length of ICU stay, measured in days
28 days
Complications
Tidsramme: 28 days
Complications (e.g. ventilator associated pneumonia and ICU acquired weakness) as reported in the patient file.
28 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Erasmus Medical Center

Samarbeidspartnere

Catharina Ziekenhuis Eindhoven
Leiden University Medical Center
Deep Breath

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

21. juli 2026

Primær fullføring (Antatt)

1. november 2026

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

13. mai 2026

Først innsendt som oppfylte QC-kriteriene

29. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. august 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MEC-2025-0353
  • EMCLSH24018 (Annet stipend/finansieringsnummer: Health~Holland)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

The final dataset will be available on reasonable request, with removed/anonymized timestamps for pseudonimization. The request will be reviewed by the PI, depending on the topic/quality of the proposal and including a plan for publication/authorship, and ensuring that the request meets legal and organizational requirements. Sharing of data for reuse by third parties will always only involve de-identified datasets and via a data transfer agreement.

IPD-delingstidsramme

IPD will be available after publication of the Clinical Study Report. IPD will be available for 10 years, in compliance with Dutch laws.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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