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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mechanical Ventilation; Patient-Ventilator Asynchrony
• Intervention / Treatment: Other: PVA classification software

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Annemijn Jonkman, PhD; Phone Number: +3110-7035142; Email: a.jonkman@erasmusmc.nl

Study Locations

• Netherlands
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623EJ
      • Catharina Ziekenhuis Eindhoven (CZE)
      • Contact: Ashley de Bie, PhD; Phone Number: +3140-2399500; Email: ashley.d.bie@catharinaziekenhuis.nl
      • Principal Investigator: Ashley de Bie, PhD
      • Sub-Investigator: Thijs Rietveld, MSc
  • South Holland
    • Leiden, South Holland, Netherlands, 2333ZA
      • Leiden University Medical Center (LUMC)
      • Sub-Investigator: Thijs Rietveld, MSc
      • Contact: Bram Schoe, PhD; Email: a.schoe@lumc.nl
      • Principal Investigator: Bram Schoe, PhD
    • Rotterdam, South Holland, Netherlands, 3015GD
      • Erasmus Medical Center (EMC)
      • Contact: Annemijn Jonkman, PhD; Phone Number: +3110-7035142; Email: a.jonkman@erasmusmc.nl
      • Principal Investigator: Annemijn Jonkman, PhD
      • Sub-Investigator: Thijs P Rietveld, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asynchrony index over time (aggregated and per PVA type)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at day 28	Mortality at day 28	28 days
Use of sedatives (cumulative dose and type)		28 days
Mechanical ventilation settings		28 days
Respiratory parameters		28 days
Hemodynamic parameters		28 days
Relevant medication	e.g. vasoactive agents, delirium related medication, analgesics	28 days
Use of assist devices	e.g. dialysis, pacemaker, ventricular assist device, ECMO	28 days
Gas exchange parameters	e.g. P/F ratio, PaO2, PaCO2, pH, bicarbonate	28 days
Blood inflammatory biomarkers	upon availability in the patient's electronic chart, e.g. CRP, lactate	28 days
Sedation depth	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	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)	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	Mortality during ICU stay	90 days
Mortality at day 90	Mortality at day 90	90 days
Duration of ventilation	Duration of ventilation in hours or days	28 days
Ventilator free days (at day 28)	Number of ventilator free days at day 28	28 days
Ventilator free days (at day 90)	Number of ventilator free days at day 90	90 days
Reintubation rate	Number of times reintubation occured, reported as % of patients needing reintubation.	28 days
Weaning success	Weaning success rate (%), defined as seven consecutive days without ventilator support	28 days
ICU length of stay	Length of ICU stay, measured in days	28 days
Complications	Complications (e.g. ventilator associated pneumonia and ICU acquired weakness) as reported in the patient file.	28 days

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Catharina Ziekenhuis Eindhoven; Leiden University Medical Center; Deep Breath

Publications and helpful links

Helpful Links

• Project overview Health~Holland

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Patient-ventilator asynchrony; mechanical ventilation; ICU; algorithm; Artificial intelligence; AI; Patient-ventilator interaction; asynchrony; dyssynchrony; classification algorithm
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Patient-Ventilator Asynchrony
• Other Study ID Numbers: MEC-2025-0353; EMCLSH24018 (Other Grant/Funding Number: Health~Holland)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: IPD will be available after publication of the Clinical Study Report. IPD will be available for 10 years, in compliance with Dutch laws.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No