Arterial Waveform Analysis for Predicting Post-induction Hypotension

NCT05756933 | Unknown

• 1 other identifier: MOST 111-2221-E-038-019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension on Induction

Keywords

Anesthesia induction; hypotension; pressure waveform; machine learning

Outcome Measures

Primary Outcomes (1)

• waveform characteristics predicting post-induction hypotension

  An equivalent circuit model will firstly be established to simulate patient's hemodynamics. This model will be applied into analyzing blood pressure waveforms in the MIMIC II database.

  Evaluated during the induction period of general anesthesia.

Secondary Outcomes (1)

• effects of induction effects of induction drugs on vessels

  off-line analysis

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving laparoscopic surgeries under general anesthesia.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Department of Anesthesia, Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chuen-Chau Chang, MD, PhD

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: August 1, 2022
• Primary Completion: November 20, 2023
• Study Completion: April 30, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)