Hypotension on Induction Clinical Trial
Official title:
Noninvasive and Continuous Arterial Waveform Analysis for Predicting Post-induction Hypotension of Endoscopic Surgery Patients.
Verified date | February 2023 |
Source | Taipei Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | April 30, 2024 |
Est. primary completion date | November 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Anesthesia, Taipei Medical University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University | National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | effects of induction effects of induction drugs on vessels | Evaluate the specific effects of anesthetics on characteristics of pressure waveform. | off-line analysis |
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