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

29. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

110

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Holland
    • North Brabant
      • Eindhoven, North Brabant, Holland, 5623EJ
        • Catharina Ziekenhuis Eindhoven (CZE)
        • Kontakt:
        • Ledende efterforsker:
          • Ashley de Bie, PhD
        • Underforsker:
          • Thijs Rietveld, MSc
    • South Holland
      • Leiden, South Holland, Holland, 2333ZA
        • Leiden University Medical Center (LUMC)
        • Underforsker:
          • Thijs Rietveld, MSc
        • Kontakt:
        • Ledende efterforsker:
          • Bram Schoe, PhD
      • Rotterdam, South Holland, Holland, 3015GD
        • Erasmus Medical Center (EMC)
        • Kontakt:
        • Ledende efterforsker:
          • Annemijn Jonkman, PhD
        • Underforsker:
          • Thijs P Rietveld, MSc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Dødelighed på dag 28
Tidsramme: 28 dage
Dødelighed på dag 28
28 dage
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Erasmus Medical Center

Samarbejdspartnere

Catharina Ziekenhuis Eindhoven
Leiden University Medical Center
Deep Breath

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. februar 2027

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MEC-2025-0353
  • EMCLSH24018 (Andet bevillings-/finansieringsnummer: Health~Holland)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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 Understøttende informationstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mekanisk ventilation

Kliniske forsøg med PVA classification software

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