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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Annemijn Jonkman, PhD
- Telefonnummer: +3110-7035142
- E-post: a.jonkman@erasmusmc.nl
Studieorter
-
-
North Brabant
-
Eindhoven, North Brabant, Nederländerna, 5623EJ
- Rekrytering
- Catharina Ziekenhuis Eindhoven (CZE)
-
Kontakt:
- Ashley de Bie, PhD
- Telefonnummer: +3140-2399500
- E-post: ashley.d.bie@catharinaziekenhuis.nl
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Huvudutredare:
- Ashley de Bie, PhD
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Underutredare:
- Thijs Rietveld, MSc
-
-
South Holland
-
Leiden, South Holland, Nederländerna, 2333ZA
- Har inte rekryterat ännu
- Leiden University Medical Center (LUMC)
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Underutredare:
- Thijs Rietveld, MSc
-
Kontakt:
- Bram Schoe, PhD
- E-post: a.schoe@lumc.nl
-
Huvudutredare:
- Bram Schoe, PhD
-
Rotterdam, South Holland, Nederländerna, 3015GD
- Rekrytering
- Erasmus Medical Center (EMC)
-
Kontakt:
- Annemijn Jonkman, PhD
- Telefonnummer: +3110-7035142
- E-post: a.jonkman@erasmusmc.nl
-
Huvudutredare:
- Annemijn Jonkman, PhD
-
Underutredare:
- Thijs P Rietveld, MSc
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Asynchrony index over time (aggregated and per PVA type)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dödlighet dag 28
Tidsram: 28 dagar
|
Dödlighet dag 28
|
28 dagar
|
|
Use of sedatives (cumulative dose and type)
Tidsram: 28 days
|
28 days
|
|
|
Mechanical ventilation settings
Tidsram: 28 days
|
28 days
|
|
|
Respiratory parameters
Tidsram: 28 days
|
28 days
|
|
|
Hemodynamic parameters
Tidsram: 28 days
|
28 days
|
|
|
Relevant medication
Tidsram: 28 days
|
e.g.
vasoactive agents, delirium related medication, analgesics
|
28 days
|
|
Use of assist devices
Tidsram: 28 days
|
e.g.
dialysis, pacemaker, ventricular assist device, ECMO
|
28 days
|
|
Gas exchange parameters
Tidsram: 28 days
|
e.g.
P/F ratio, PaO2, PaCO2, pH, bicarbonate
|
28 days
|
|
Blood inflammatory biomarkers
Tidsram: 28 days
|
upon availability in the patient's electronic chart, e.g.
CRP, lactate
|
28 days
|
|
Sedation depth
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 90 days
|
Mortality during ICU stay
|
90 days
|
|
Mortality at day 90
Tidsram: 90 days
|
Mortality at day 90
|
90 days
|
|
Duration of ventilation
Tidsram: 28 days
|
Duration of ventilation in hours or days
|
28 days
|
|
Ventilator free days (at day 28)
Tidsram: 28 days
|
Number of ventilator free days at day 28
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28 days
|
|
Ventilator free days (at day 90)
Tidsram: 90 days
|
Number of ventilator free days at day 90
|
90 days
|
|
Reintubation rate
Tidsram: 28 days
|
Number of times reintubation occured, reported as % of patients needing reintubation.
|
28 days
|
|
Weaning success
Tidsram: 28 days
|
Weaning success rate (%), defined as seven consecutive days without ventilator support
|
28 days
|
|
ICU length of stay
Tidsram: 28 days
|
Length of ICU stay, measured in days
|
28 days
|
|
Complications
Tidsram: 28 days
|
Complications (e.g.
ventilator associated pneumonia and ICU acquired weakness) as reported in the patient file.
|
28 days
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MEC-2025-0353
- EMCLSH24018 (Annat bidrag/finansieringsnummer: Health~Holland)
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
Tidsram för IPD-delning
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
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