Post-induction (and intra-operative) hypotension is a frequent finding in patients scheduled for surgery or intubation/tracheostomy in the ICU, and with the development of a machine learning model, we will be able to predict hypotensvie episodes…
ID
Bron
Verkorte titel
Aandoening
Post-induction hypotension, intra-operative hypotension, acute kidney injury, stroke, myocardial injury, mortality.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Collection of continuous noninvasive arterial pressure waveform signals with the ClearSight and clinical data to be used to predict the likelihood of derangement of physiologic parameters in awake patients before induction of anesthesia and to predict the occurrence of post-induction hypotension using machine learning.
Achtergrond van het onderzoek
Hypotension during surgery is associated with increased morbidity and mortality. The majority of patients will have post-induction hypotension (PIH), a mean arterial blood pressure below 65 mmHg for at least one minute and occurring during the first 20 min after anesthesia induction. PIH is highly prevalent and probably occurs more often than intraoperative hypotension.
PIH is very likely to have an equally negative effect on outcome as any other type of intra-operative hypotension. Even short periods of hypotension are known to contribute to the occurrence of postoperative renal failure, myocardial injury, stroke and length of hospital stay.
The early identification and treatment of hypotension is clinically relevant. Current therapies are reactive and are started after hypotension occurs. Post-induction hypotension (PIH) is likely to occur in the majority of cases in the face of boluses of anesthetic agents causing severe vasodilation and even temporary cardiac depression as a surgical stimulus is missing. Since any type of hypotension is likely to have negative effects, prevention is warranted. A machine learning algorithm based on the arterial pressure signal for the prediction of PIH, in analogy of the recently FDA-approved intra-operative Hypotension Prediction Index, would eventually allow preemptive treatment and prevention of post-induction hypotension altogether.
The primary aim of this study is data collection of continuous noninvasive arterial pressure waveform signals with the ClearSight finger cuff and clinical data from patients’ electronic medical record in surgical patients and Intensive Care Unit patients who need intubation or elective tracheostomy, to be used to predict the likelihood of derangement of physiologic parameters in awake patients before induction of anesthesia and to predict the occurrence of post-induction hypotension and intra-operative hypotension using machine learning.
Doel van het onderzoek
Post-induction (and intra-operative) hypotension is a frequent finding in patients scheduled for surgery or intubation/tracheostomy in the ICU, and with the development of a machine learning model, we will be able to predict hypotensvie episodes following administration of anesthetic agents.
Onderzoeksopzet
Patients will be connected to the ClearSight system 30 minutes prior to start of induction of anesthesia. Data will be continuously collected until at least 30 minutes after start of surgery, or until 20 minutes after start induction (for ICU patients).
Onderzoeksproduct en/of interventie
Not applicable.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 18 years or older
- Planned for any type of elective surgery or for intubation/tracheostomy in the ICU
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Any right-sided structural pathology or reduced function (Tapse <1.5cm)
- Severe cardiac arrhythmias (with high heart rate), including atrial fibrillation
- Abnormal anatomy of the fingers
- Emergency surgery
- Noninvasive blood pressure (with the finger cuff) or invasive blood pressure (with an arterial cannula) can not be measured
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL7810 |
Ander register | METC AMC : METC 2018_271, NL67484.018.18 |