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| ID | Type | Description | Link |
|---|---|---|---|
| EMCLSH24018 | Other Grant/Funding Number | Health~Holland |
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| Name | Class |
|---|---|
| Deep Breath | UNKNOWN |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Leiden University Medical Center | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Use of sedatives (cumulative dose and type) | 28 days | |
| Mechanical ventilation settings | 28 days | |
| Respiratory parameters |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted to the ICU that receive invasive mechanical ventilation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annemijn Jonkman, PhD | Contact | +3110-7035142 | a.jonkman@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Ziekenhuis Eindhoven (CZE) | Eindhoven | North Brabant | 5623EJ | Netherlands |
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| Label | URL |
|---|---|
| Project overview Health\~Holland | View source |
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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 will be available after publication of the Clinical Study Report. IPD will be available for 10 years, in compliance with Dutch laws.
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| ID | Term |
|---|---|
| D000097742 | Patient-Ventilator Asynchrony |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| 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 28 | Mortality at day 28 | 28 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 |
| Leiden University Medical Center (LUMC) | Leiden | South Holland | 2333ZA | Netherlands |
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| Erasmus Medical Center (EMC) | Rotterdam | South Holland | 3015GD | Netherlands |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |