Clinical trial NCT05756933: Arterial Waveform Analysis for Predicting Post-induction Hypotension
Official title: Noninvasive and Continuous Arterial Waveform Analysis for Predicting Post-induction Hypotension of Endoscopic Surgery Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension on Induction
Keywords: Anesthesia induction
hypotension
pressure waveform
machine learning
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2023-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving laparoscopic surgeries under general anesthesia.

Brief summary: The goal of this observational study is to develop a computation model for accurately predicting post-induction hypotension in patients receiving laparoscopic surgery under general anesthesia. The main question\[s\] it aims to answer are:

• whether the corresponding characteristics on pressure wave forms could be use to predict post-induction hypotension.

Participants will be observed before and after induction of general anesthesia for non-invasive arterial pressure wave forms and blood pressure changes.

Detailed description: In this project, an equivalent circuit model will firstly be established to simulate patient's hemodynamics. This model will be applied into analyzing blood pressure wave forms in the MIMIC II database. It will facilitate deep understanding of the effects of induction drugs on pressure waveforms. As a result, the corresponding characteristics on pressure wave forms will be identified. The extracted characteristics from the MIMIC II database will then be applied for developing a computation model via machining learning approaches. The developed model will be validated with another available dataset of 100 patients. This project will then conduct a non-invasive and observational clinical study of 50 patients to prove the clinical value of this project. In this trial, a novel pressure sensor will be employed on patient's fingertip to continuously collect pressure waveform before and after anesthesia induction. Medical records and vital signs will also be collected for exploring the potential of the developed model for predicting other events. Endoscopic surgery patients will be recruited in this study.

Eligibility criteria: Inclusion Criteria:

* Age \>= 20 years
* Ease of access to the hand used for the ArteVu device during the one-hour it is being used during the operation.
* Able to provide written informed consent for participation in the study.

Exclusion Criteria:

* Pregnant patients.
* Medical or surgical condition that prevents the ability to apply the ArteVu device on an upper extremity finger for a period of one-hour during anesthesia and operation.
* Impaired skin integrity of the fingers (e.g. injuries to the finger, burn injuries, or skin graft surgery on the finger).
* Operations involving the upper extremities or the blood vessels of the upper extremities.
* Arthritis or severe deformities of the hand and fingers
* Prosthetic devices or jewelry (such as a wedding band) that cannot be removed from the finger to be used for the ArteVu device.
* History of malignant hyperthermia
* Raynaud's disease affecting the fingers or hands.
* Topical allergy to ABS or silicone
* Swelling, edema or lymphedema of the upper extremity
* Participants with upper extremity occlusive peripheral vascular diseases
* Inability of the patient to provide written informed consent.

Primary outcomes:
measure: waveform characteristics predicting post-induction hypotension
timeFrame: Evaluated during the induction period of general anesthesia.
Secondary outcomes:
measure: effects of induction effects of induction drugs on vessels
timeFrame: off-line analysis
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesia, Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Chuen-Chau Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: