Clinical Study of Combined Carotid Artery With Inferior Vena Cava Ultrasonography to Predict Hypotension After Induction of General Anesthesia

Sponsor
Tongji Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05472025
Collaborator
(none)
106
1
8.7
12.1

Study Details

Study Description

Brief Summary

Studies have shown that the clinical application of ultrasound to measure large blood vessels related parameters has been widely used to assess the blood volume status of patients, with the advantages of simple, non-invasive and non-radioactive, etc. However, these current methods using by ultrasound technology such as diameter and collapsibility index of the inferior vena cava parameters cannot fully reflect the blood volume, the sensitivity and specificity of predicting hypotension after induction are not very satisfied. Recent reports have demonstrated that respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak) and carotid corrected flow time (FTc) can noninvasively assess patient responsiveness to fluids. Thus, we speculate that the combined measurement of the parameters of the carotid artery and the inferior vena cava may more comprehensively and accurately assess the patient's blood volume status, thereby accurately predicting the occurrence of hypotension after induction of anesthesia.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hypotension is common after induction of general anesthesia, with an incidence of 9% to 90%. Hypotension after induction of anesthesia may increase the risk of cardiovascular and cerebrovascular accidents, postoperative cognitive dysfunction, as well as increase the risk of postoperative acute myocardial injury and increase the mortality rate during hospitalization. The aim of this study is to establish an assessment method that can effectively predict hypotension after induction of anesthesia, so as to prevent possible harm to patients from perioperative hypotension. The study is planned to measure the peak flow velocity variation and corrected blood flow time of the carotid artery, the diameter and cross-sectional area of the inferior vena cava by applying ultrasound before anesthesia, and record the blood pressure and heart rate before induction of anesthesia, and the blood pressure and heart rate per minute within 10 minutes after induction of tracheal intubation. The mean arterial pressure (MAP) was recorded as the basal value before induction of anesthesia. After induction of anesthesia, MAP < 60 mmHg, or a decrease of more than 30% of the basal value, was defined as the occurrence of hypotension.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    106 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Clinical Study of Combined Carotid Artery With Inferior Vena Cava Ultrasonography to Predict Hypotension After Induction of General Anesthesia: a Prospective Study
    Anticipated Study Start Date :
    Aug 7, 2022
    Anticipated Primary Completion Date :
    Apr 30, 2023
    Anticipated Study Completion Date :
    Apr 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Changes in blood pressure

    Blood pressure assessment:The blood pressure and heart rate before induction and the blood pressure and heart rate per minute within 10 minutes after induction intubation were recorded. After induction of anesthesia, MAP < 60 mmHg, or the decrease rate exceeded 30% of the baseline value, was defined as the occurrence of hypotension

    Outcome Measures

    Primary Outcome Measures

    1. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [Before induction of anesthesia]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    2. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [After induction of anesthesia to before tracheal intubation]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    3. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [after induction of anesthesia tracheal intubation 1 minute]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    4. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [after induction of anesthesia tracheal intubation 2 minute]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    5. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [after induction of anesthesia tracheal intubation 3 minute]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    6. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [after induction of anesthesia tracheal intubation 4 minute]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    7. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [after induction of anesthesia tracheal intubation 5 minutes]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    8. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [after induction of anesthesia tracheal intubation 6 minute]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    9. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [after induction of anesthesia tracheal intubation 7 minutes]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    10. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [after induction of anesthesia tracheal intubation 8 minutes]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    11. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [after induction of anesthesia tracheal intubation 9 minutes]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    12. Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography [after induction of anesthesia tracheal intubation 10 minutes]

      Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients who are scheduled to undergo surgery under general anesthesia

    2. Age ≥ 18 years old

    3. ASA I or II

    4. The patient is clearly conscious and has the ability to cooperate with the ultrasound measurement

    5. The patient signed the informed consent

    Exclusion Criteria:
    1. Emergency surgery

    2. Consciousness disorder or mental disorder before surgery

    3. Sudden emergency vital sign changes before surgery, life-threatening patients

    4. Patients with preoperative respiratory distress, elevated intra-abdominal pressure, and expected difficult airway

    5. Patients with preoperative autonomic nervous system disease

    6. Patients with implantable pacemaker or cardioverter

    7. Patients with preoperative peripheral vascular disease, severe cardiovascular disease, unstable angina or cardiac ejection fraction less than 40%

    8. Pregnant women

    9. Carotid artery stenosis

    10. Severe carotid plaque

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital Wuhan Hubei China 430030

    Sponsors and Collaborators

    • Tongji Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Feng Gao, Director, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT05472025
    Other Study ID Numbers:
    • TJ2022S073
    First Posted:
    Jul 25, 2022
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Feng Gao, Director, Tongji Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2022