Health TrialsbyHealthPanel

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

ConditionsMechanical VentilationPatient-Ventilator Asynchrony
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

(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 population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • PVA classification software

    Other intervention

    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.

Treatment groups

110 Participants
are divided into 1 treatment group
Group A: Adult patients admitted to the ICU that receive invasive mechanical ventilation1 intervention

Trial outcomes

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).

Time frame
28 days

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

Deep Breath

Collaborator

Catharina Ziekenhuis Eindhoven

Collaborator

Leiden University Medical Center

Collaborator

Source ClinicalTrials.gov
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