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Status unknownNCT05756933Updated Nov 22, 2023

Arterial Waveform Analysis for Predicting Post-induction Hypotension

An observational study in Hypotension on Induction, sponsored by Taipei Medical University. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Taipei Medical University · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypotension on Induction

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Keywords

  • Anesthesia induction
  • hypotension
  • pressure waveform
  • machine learning
03

In context

Hypotension

1,021 studies on the registry are indexed under Hypotension; 172 are open to participants now.

This study's planned enrollment of 50 is below the median of 84 across 301 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 256 studies on the registry; 59 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receiving laparoscopic surgeries under general anesthesia.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: Evaluated during the induction period of general anesthesia.

Secondary outcomes

  1. effects of induction effects of induction drugs on vessels

    Evaluate the specific effects of anesthetics on characteristics of pressure waveform.

    Time frame: off-line analysis

07

Study locations

1 site
  • Department of Anesthesia, Taipei Medical University Hospital
    Taipei, 110, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2022 to primary completion in Nov 2023, 15 months.

Of 169 non-industry observational studies under Hypotension, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's 15 months is above that.

Counting every sponsor, half of 177 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2023
First posted
Mar 7, 2023
StartActual
Aug 1, 2022
Primary completionActual
Nov 20, 2023
CompletionEst.
Apr 30, 2024
Last update
Nov 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05756933
Lead sponsor
Taipei Medical University
Collaborators
National Science and Technology Council, Taiwan
Responsible party
Sponsor
First posted
Mar 7, 2023
Start date
Aug 1, 2022
Primary completion
Nov 20, 2023
Completion
Apr 30, 2024 (estimated)
Last update
Nov 22, 2023

Study contacts

Chuen-Chau Chang, MD, PhD
principal investigator · Taipei Medical University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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