Prediction of Post-induction Hypotension with Arterial Pulse wave applied Machine Learning, a non-randomized prospective data collection observational study.

Prediction of Post-induction Hypotension with Arterial Pulse wave applied Machine Learning, a non-randomized prospective data collection observational study. - PREP trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52930

Enrollment

1300

Registered

2018-12-13

Start date

2019-01-07

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamiek, intra-operatief hypotension low blood pressure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Elective surgical patients: - >=18 years of age - Informed consent - Planned for any type of elective surgery Intensive Care Unit patients requiring intubation: - >= 18 years of age - Informed consent or deferred consent - Requiring (emergency) intubation Intensive Care Unit patients requiring elective tracheostomy: - >= 18 years of age - Informed consent or deferred consent - Requiring elective tracheostomy

Exclusion criteria

Exclusion criteria: Elective surgical patients: - Any right-sided structural pathology or reduced cardiac function (Tapse

Design outcomes

Primary

Measure	Time frame
The primary aim of this study is data collection of continuous noninvasive arterial pressure waveform signals with the CS finger cuff, continuous invasive arterial pressure waveform signals when an arterial cannula is already available due to standard of care, continuous noninvasive cerebral oximetry signals and clinical data from patients EMR in surgical and ICU patients. These data will 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 IOH using machine learning. The collected digital pressure waveform data will be used to assess the feasibility, the learning and building of an initial ML model using the CS/EV1000/HemoSphere continuous noninvasive arterial pressure signal and internally validate it. The collected data will be used to assess whether the non-invasive arterial pressure waveform measured at the finger level using the CS/EV1000/HemoSphere system or the invasive arterial pressure waveform measured with an arterial cannula exhibits any distinctive morphological characteristics in awake patients having post-induction hypotension, defined as MAP	—

Measure

Time frame

The primary aim of this study is data collection of continuous noninvasive arterial pressure waveform signals with the CS finger cuff, continuous invasive arterial pressure waveform signals when an arterial cannula is already available due to standard of care, continuous noninvasive cerebral oximetry signals and clinical data from patients EMR in surgical and ICU patients. These data will 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 IOH using machine learning. The collected digital pressure waveform data will be used to assess the feasibility, the learning and building of an initial ML model using the CS/EV1000/HemoSphere continuous noninvasive arterial pressure signal and internally validate it. The collected data will be used to assess whether the non-invasive arterial pressure waveform measured at the finger level using the CS/EV1000/HemoSphere system or the invasive arterial pressure waveform measured with an arterial cannula exhibits any distinctive morphological characteristics in awake patients having post-induction hypotension, defined as MAP

—

Secondary

Measure	Time frame
Secondary aim is the correlation between severity of post-induction hypotension, waveform and cerebral oximetry data, patient history characteristics and the incidence and severity of hypotension during the surgical procedure or the intubation or elective tracheostomy in the ICU.	—

Countries

Netherlands

Outcome results