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NCT Number: NCT07624786

Patient-Ventilator Asynchrony: Occurence and Clinical Impact 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.

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Key information

Conditions

Mechanical Ventilation Pathological Conditions, Signs and Symptoms Patient-Ventilator Asynchrony Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Ziekenhuis Eindhoven (CZE), Eindhoven, North Brabant, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVA classification software

Other

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.

Primary outcomes

  1. Asynchrony index over time (aggregated and per PVA type)

    Time frame: 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).

Secondary outcomes

  1. Use of sedatives (cumulative dose and type)

    Time frame: 28 days

  2. Mechanical ventilation settings

    Time frame: 28 days

  3. Respiratory parameters

    Time frame: 28 days

  4. Hemodynamic parameters

    Time frame: 28 days

  5. Relevant medication

    Time frame: 28 days

    e.g. vasoactive agents, delirium related medication, analgesics

  6. Use of assist devices

    Time frame: 28 days

    e.g. dialysis, pacemaker, ventricular assist device, ECMO

  7. Gas exchange parameters

    Time frame: 28 days

    e.g. P/F ratio, PaO2, PaCO2, pH, bicarbonate

  8. Blood inflammatory biomarkers

    Time frame: 28 days

    upon availability in the patient's electronic chart, e.g. CRP, lactate

  9. Sedation depth

    Time frame: 28 days

    Richmond Agitation-Sedation Scale (RASS-score). This score ranges from -5 to +4, where a more positive score indicates more agitation.

  10. Reported delirium

    Time frame: 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.

  11. Illness severity score (SOFA-score)

    Time frame: 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.

  12. ICU mortality

    Time frame: 90 days

    Mortality during ICU stay

  13. Mortality at day 28

    Time frame: 28 days

    Mortality at day 28

  14. Mortality at day 90

    Time frame: 90 days

    Mortality at day 90

  15. Duration of ventilation

    Time frame: 28 days

    Duration of ventilation in hours or days

  16. Ventilator free days (at day 28)

    Time frame: 28 days

    Number of ventilator free days at day 28

  17. Ventilator free days (at day 90)

    Time frame: 90 days

    Number of ventilator free days at day 90

  18. Reintubation rate

    Time frame: 28 days

    Number of times reintubation occured, reported as % of patients needing reintubation.

  19. Weaning success

    Time frame: 28 days

    Weaning success rate (%), defined as seven consecutive days without ventilator support

  20. ICU length of stay

    Time frame: 28 days

    Length of ICU stay, measured in days

  21. Complications

    Time frame: 28 days

    Complications (e.g. ventilator associated pneumonia and ICU acquired weakness) as reported in the patient file.

Study contacts

Contact information is provided by the study sponsor or research team.

Annemijn Jonkman, PhD

CONTACT

[email protected]

+3110-7035142

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Catharina Ziekenhuis Eindhoven
  • Deep Breath
  • Leiden University Medical Center

Registry information

Official study title

Unraveling the Clinical Impact of Patient-Ventilator Asynchrony in Usual Care

Acronym: PVA-detection

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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