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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Annemijn Jonkman, PhD
- 電話番号：+3110-7035142
- メール：a.jonkman@erasmusmc.nl
研究場所
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North Brabant
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Eindhoven、North Brabant、オランダ、5623EJ
- 募集
- Catharina Ziekenhuis Eindhoven (CZE)
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コンタクト：
- Ashley de Bie, PhD
- 電話番号：+3140-2399500
- メール：ashley.d.bie@catharinaziekenhuis.nl
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主任研究者：
- Ashley de Bie, PhD
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副調査官：
- Thijs Rietveld, MSc
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South Holland
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Leiden、South Holland、オランダ、2333ZA
- まだ募集していません
- Leiden University Medical Center (LUMC)
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副調査官：
- Thijs Rietveld, MSc
-
コンタクト：
- Bram Schoe, PhD
- メール：a.schoe@lumc.nl
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主任研究者：
- Bram Schoe, PhD
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Rotterdam、South Holland、オランダ、3015GD
- 募集
- Erasmus Medical Center (EMC)
-
コンタクト：
- Annemijn Jonkman, PhD
- 電話番号：+3110-7035142
- メール：a.jonkman@erasmusmc.nl
-
主任研究者：
- Annemijn Jonkman, PhD
-
副調査官：
- Thijs P Rietveld, MSc
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Asynchrony index over time (aggregated and per PVA type)
時間枠：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).
|
28 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
28日目の死亡率
時間枠：28日
|
28日目の死亡率
|
28日
|
|
Use of sedatives (cumulative dose and type)
時間枠：28 days
|
28 days
|
|
|
Mechanical ventilation settings
時間枠：28 days
|
28 days
|
|
|
Respiratory parameters
時間枠：28 days
|
28 days
|
|
|
Hemodynamic parameters
時間枠：28 days
|
28 days
|
|
|
Relevant medication
時間枠：28 days
|
e.g.
vasoactive agents, delirium related medication, analgesics
|
28 days
|
|
Use of assist devices
時間枠：28 days
|
e.g.
dialysis, pacemaker, ventricular assist device, ECMO
|
28 days
|
|
Gas exchange parameters
時間枠：28 days
|
e.g.
P/F ratio, PaO2, PaCO2, pH, bicarbonate
|
28 days
|
|
Blood inflammatory biomarkers
時間枠：28 days
|
upon availability in the patient's electronic chart, e.g.
CRP, lactate
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28 days
|
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Sedation depth
時間枠：28 days
|
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
時間枠：28 days
|
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)
時間枠：28 days
|
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
|
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ICU mortality
時間枠：90 days
|
Mortality during ICU stay
|
90 days
|
|
Mortality at day 90
時間枠：90 days
|
Mortality at day 90
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90 days
|
|
Duration of ventilation
時間枠：28 days
|
Duration of ventilation in hours or days
|
28 days
|
|
Ventilator free days (at day 28)
時間枠：28 days
|
Number of ventilator free days at day 28
|
28 days
|
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Ventilator free days (at day 90)
時間枠：90 days
|
Number of ventilator free days at day 90
|
90 days
|
|
Reintubation rate
時間枠：28 days
|
Number of times reintubation occured, reported as % of patients needing reintubation.
|
28 days
|
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Weaning success
時間枠：28 days
|
Weaning success rate (%), defined as seven consecutive days without ventilator support
|
28 days
|
|
ICU length of stay
時間枠：28 days
|
Length of ICU stay, measured in days
|
28 days
|
|
Complications
時間枠：28 days
|
Complications (e.g.
ventilator associated pneumonia and ICU acquired weakness) as reported in the patient file.
|
28 days
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- MEC-2025-0353
- EMCLSH24018 (その他の助成金/資金番号：Health~Holland)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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