Patient-Ventilator Asynchrony: Occurence and Clinical Impact in Usual Care

NCT07624786 | Not Yet Recruiting

• 2 other identifiers: MEC-2025-0353EMCLSH24018
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Mechanical Ventilation; Patient-Ventilator Asynchrony

Keywords

asynchrony; Patient-ventilator asynchrony; dyssynchrony; Patient-ventilator interaction; mechanical ventilation; AI; algorithm; classification algorithm; ICU; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Use of sedatives (cumulative dose and type)

  28 days

• Mechanical ventilation settings

  28 days

• Respiratory parameters

  28 days

• Hemodynamic parameters

  28 days

• Relevant medication

  28 days

Study Arms (1)

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

Interventions

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.

Adult patients admitted to the ICU that receive invasive mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• (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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Deep Breath: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Leiden University Medical Center: collaborator

Study Sites (3)

Catharina Ziekenhuis Eindhoven (CZE)

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Leiden University Medical Center (LUMC)

Leiden, South Holland, 2333ZA, Netherlands

Location

Erasmus Medical Center (EMC)

Rotterdam, South Holland, 3015GD, Netherlands

Location

Related Links

• Project overview Health\~Holland

MeSH Terms

Conditions

Patient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Annemijn Jonkman, PhD

CONTACT

+3110-7035142; a.jonkman@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Principal Investigator

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• 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.

Locations

NL (3)