Mechanical VentilationPVA-detectionNCT07624786
Patient-Ventilator Asynchrony: Occurence and Clinical Impact in Usual Care
An observational study of Mechanical Ventilation and Patient-Ventilator Asynchrony, run by Erasmus Medical Center at 3 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Patient-Ventilator Asynchrony
- What is being tested?
- PVA classification software
- How many people
- 110 participants
- Where
- 3 sitesNetherlands
- Study dates
- 21 Jul 2026to Feb 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the ICU that receive invasive mechanical ventilation.
Who may be able to join
- 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.
Who cannot join
- (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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Catharina Ziekenhuis Eindhoven (CZE)
Eindhoven, North Brabant, 5623EJ
Ashley de Bie, PhD, +3140-2399500, ashley.d.bie@catharinaziekenhuis.nl
Ashley de Bie, PhD
- Not yet recruiting
Leiden University Medical Center (LUMC)
Leiden, South Holland, 2333ZA
Bram Schoe, PhD, a.schoe@lumc.nl
Bram Schoe, PhD
- Recruiting
Erasmus Medical Center (EMC)
Rotterdam, South Holland, 3015GD
Annemijn Jonkman, PhD, +3110-7035142, a.jonkman@erasmusmc.nl
Annemijn Jonkman, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- PVA classification software
- Keywords
- asynchrony, Patient-ventilator asynchrony, dyssynchrony, Patient-ventilator interaction, mechanical ventilation, AI, algorithm, classification algorithm, ICU, Artificial intelligence
- Medical subject headings
- Patient-Ventilator Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVA classification softwareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PVA classification software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28 days
Secondary outcomes (21)
Use of sedatives (cumulative dose and type)
Measured: 28 days
Mechanical ventilation settings
Measured: 28 days
Respiratory parameters
Measured: 28 days
Hemodynamic parameters
Measured: 28 days
Relevant medication
e.g. vasoactive agents, delirium related medication, analgesics
Measured: 28 days
Use of assist devices
e.g. dialysis, pacemaker, ventricular assist device, ECMO
Measured: 28 days
Gas exchange parameters
e.g. P/F ratio, PaO2, PaCO2, pH, bicarbonate
Measured: 28 days
Blood inflammatory biomarkers
upon availability in the patient's electronic chart, e.g. CRP, lactate
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days
ICU mortality
Mortality during ICU stay
Measured: 90 days
Mortality at day 28
Mortality at day 28
Measured: 28 days
Mortality at day 90
Mortality at day 90
Measured: 90 days
Duration of ventilation
Duration of ventilation in hours or days
Measured: 28 days
Ventilator free days (at day 28)
Number of ventilator free days at day 28
Measured: 28 days
Ventilator free days (at day 90)
Number of ventilator free days at day 90
Measured: 90 days
Reintubation rate
Number of times reintubation occured, reported as % of patients needing reintubation.
Measured: 28 days
Weaning success
Weaning success rate (%), defined as seven consecutive days without ventilator support
Measured: 28 days
ICU length of stay
Length of ICU stay, measured in days
Measured: 28 days
Complications
Complications (e.g. ventilator associated pneumonia and ICU acquired weakness) as reported in the patient file.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start21 Jul 2026
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 110 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Deep Breath, Catharina Ziekenhuis Eindhoven, Leiden University Medical Center
- Responsible party
- Principal investigator, Annemijn Jonkman, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624786
- Sponsor's protocol ID
- MEC-2025-0353
- Other IDs
- EMCLSH24018
- Acronym
- PVA-detection
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling the Clinical Impact of Patient-Ventilator Asynchrony in Usual Care
- ClinicalTrials.gov ID
- NCT07624786
- Acronym / sponsor ID
- PVA-detection / MEC-2025-0353
- Keywords
- asynchrony, Patient-ventilator asynchrony, dyssynchrony, Patient-ventilator interaction, mechanical ventilation, AI, algorithm, classification algorithm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Deep Breath, Catharina Ziekenhuis Eindhoven, Leiden University Medical Center
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients admitted to the ICU that receive invasive mechanical ventilation | – | Other: PVA classification softwarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the ICU that receive invasive mechanical ventilation.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVA classification softwarePatients 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. | Other | Adult patients admitted to the ICU that receive invasive mechanical ventilation |
Primary outcome
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).
21 secondary outcomes
Use of sedatives (cumulative dose and type)
Time frame: 28 days
Mechanical ventilation settings
Time frame: 28 days
Respiratory parameters
Time frame: 28 days
Hemodynamic parameters
Time frame: 28 days
Relevant medication
Time frame: 28 days
Use of assist devices
Time frame: 28 days
Gas exchange parameters
Time frame: 28 days
Blood inflammatory biomarkers
Time frame: 28 days
Sedation depth
Time frame: 28 days
Reported delirium
Time frame: 28 days
Illness severity score (SOFA-score)
Time frame: 28 days
ICU mortality
Time frame: 90 days
Mortality at day 28
Time frame: 28 days
Mortality at day 90
Time frame: 90 days
Duration of ventilation
Time frame: 28 days
Ventilator free days (at day 28)
Time frame: 28 days
Ventilator free days (at day 90)
Time frame: 90 days
Reintubation rate
Time frame: 28 days
Weaning success
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Complications
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Project overview Health\~HollandLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Patient-Ventilator Asynchrony, run by Erasmus Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemijn Jonkman, PhD (+3110-7035142, a.jonkman@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asynchrony index over time (aggregated and per PVA type) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.