Using Artificial Intelligence (AI)-Assisted Pulse Diagnosis Analysis on Precision Critical Medicine.

NCT04675424 | Completed

• 1 other identifier: NMRPG3K6131
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Precision/personalized medicine becomes an important part of modern medical system in the recent years. In the past, the treatments for patients have been decided by doctors according patients' symptoms and/or regular biochemical profiles. However, it is not uncommon that patients' condition varies tremendously even they have same diagnosis, and under such condition, treatment efficacy may be limited due to the heterogeneity among patients. Therefore, lack of therapeutic efficacy may be not really ineffective, and the main reason may be inadequate patient classification. For this reason, the "omics"-based personal/precision medicine emerges recently and becomes more and more important. However, in contrast to feasible and common "personalized" medicine, the approach of precision medicine to the molecular medicine level is still difficult, especially among patients in intensive critical units (ICUs). In contrast to cancer, which has remarkable advances in the past decades, the precision/personal medicine is more difficult in critical and emergent medicine. One reason is the amount of omics data is quite huge and thus dealing with omics data is time consuming. Therefore, it is not effective in daily clinical practice in ICUs care. For this condition, the investigators propose that the combination of clinical data, including pulse diagnosis by traditional Chinese medicine (TCM) doctor or ANSwatch wrist sphygmomanometer, fluid responsiveness by "Masimo" Radical-7 Pulse CO-Oximeter, and the specific database from monitors in ICUs may be a feasible way to predict outcome among ICU patients. There are two main goals for this study: (1) After establishing clinical traditional Chinese medicine (TCM) pulse diagnosis and ICU clinical parameters databases, acquiring and features of pulse diagnosis by applying AI and (2) analyzing the correlations between the features of pulse diagnosis and important clinical parameters.

Conditions

ICU Patients; Shock

Keywords

traditional Chinese medicine; pulse diagnosis; artificial intelligence; precision critical medicine

Outcome Measures

Primary Outcomes (2)

• 28-days mortality

  The investigators track the enrolled ICU patients for 28 days and record the date and cause of participants' death.

  28 days

• Pulse diagnosis

  Pulse diagnosis in radial artery is recorded by traditional Chinese medicine physician and ANSwatch wrist sphygmomanometer at the same time. With the help of artificial intelligence, the investigators will find the correlation/comparison of pulse diagnosis by physician or machine and hope to define which pulse waveform characteristics could predict the prognosis/outcome in ICU patients.

  Day1, Day4, Day8, Day11, Day15, Day18, Day22, Day25

Secondary Outcomes (3)

• Hemodynamic status

  Day1, Day4, Day8, Day11, Day15, Day18, Day22, Day25

• Fluid-responsiveness

  Day1, Day4, Day8, Day11, Day15, Day18, Day22, Day25

• Heart rate variability

  Day1, Day4, Day8, Day11, Day15, Day18, Day22, Day25,

Interventions

ANSwatch DEVICE

ANSwatch wrist sphygmomanometer and the specific database from monitors in ICUs may be a feasible way to predict outcome among ICU patients. Two measurements will be obtained: 1. Pulse diagnosis: Pulse diagnosis done on radial artery is recorded by traditional Chinese medicine physician and ANSwatch wrist sphygmomanometer at the same time. 2. Heart rate variability: Heart Rate Variability represents significant information on autonomic nervous system (ANS)'s regulating function and balance status.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The ICU patient under acute circulatory failure

You may qualify if:

• The patient in ICU is willing to participate in the research project or patient's family member is willing patient to participate in the research project.
• Acute circulatory failure

You may not qualify if:

• \. The patient do not want to participate in the research project or patient's family member do not want the patient to participate in the research project.
• \. Pregnant woman.
• \. Goals of treatment is palliative care.
• \. Patient is heritable immunodeficiency or acquired immunodeficiency.
• \. Known existing cardiac arrhythmia, valvular heart disease, right ventricular dysfunction, intra-cardiac shunt, air leaking from chest drains, abdominal compartment syndrome.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou branch

Taoyuan District, 33378, Taiwan

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: December 19, 2020
• Study Start: November 15, 2020
• Primary Completion: September 6, 2022
• Study Completion: October 6, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

TW (1)