Hypotension on InductionNCT05756933
Arterial Waveform Analysis for Predicting Post-induction Hypotension
An observational study of Hypotension on Induction, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypotension on Induction
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving laparoscopic surgeries under general anesthesia.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesia, Taipei Medical University Hospital
Taipei, 110
About this study
Official title: Noninvasive and Continuous Arterial Waveform Analysis for Predicting Post-induction Hypotension of Endoscopic Surgery Patients.
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.
- Conditions
- Hypotension on Induction
- Keywords
- Anesthesia induction, hypotension, pressure waveform, machine learning
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: off-line analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Aug 2022
- Primary completion20 Nov 2023
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chuen-Chau Chang, MD, PhD, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756933
- Sponsor's protocol ID
- MOST 111-2221-E-038-019
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive and Continuous Arterial Waveform Analysis for Predicting Post-induction Hypotension of Endoscopic Surgery Patients.
- ClinicalTrials.gov ID
- NCT05756933
- Acronym / sponsor ID
- MOST 111-2221-E-038-019
- Conditions
- Hypotension on Induction
- Keywords
- Anesthesia induction, hypotension, pressure waveform, machine learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving laparoscopic surgeries under general anesthesia.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
waveform characteristics predicting post-induction hypotension
Time frame: Evaluated during the induction period of general anesthesia.
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.
1 secondary outcome
effects of induction effects of induction drugs on vessels
Time frame: off-line analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuen-Chau Chang, MD, PhD principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension on Induction, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waveform characteristics predicting post-induction hypotension (time frame: Evaluated during the induction period of general anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.