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Status unknownNCT05472025Updated Oct 21, 2022

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

An observational study in Ultrasound Guidance, sponsored by Tongji Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-10-21.

Sponsored by Tongji Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
106
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ultrasound Guidance

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Keywords

  • ultrasound
  • carotid artery
  • inferior vena cava
  • hypotension
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's planned enrollment of 106 is above the median of 84 across 294 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Conscious adult patients with normal intra-abdominal pressure; no patients with severe diabetes, no severe carotid stenosis and plaque

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

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
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Study design

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

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

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

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

    Time frame: Before induction of anesthesia

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

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

    Time frame: After induction of anesthesia to before tracheal intubation

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

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

    Time frame: after induction of anesthesia tracheal intubation 1 minute

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

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

    Time frame: after induction of anesthesia tracheal intubation 2 minute

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

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

    Time frame: after induction of anesthesia tracheal intubation 3 minute

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

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

    Time frame: after induction of anesthesia tracheal intubation 4 minute

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

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

    Time frame: after induction of anesthesia tracheal intubation 5 minutes

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

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

    Time frame: after induction of anesthesia tracheal intubation 6 minute

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

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

    Time frame: after induction of anesthesia tracheal intubation 7 minutes

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

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

    Time frame: after induction of anesthesia tracheal intubation 8 minutes

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

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

    Time frame: after induction of anesthesia tracheal intubation 9 minutes

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

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

    Time frame: after induction of anesthesia tracheal intubation 10 minutes

07

Study locations

1 of 1 sites recruiting
  • Tongji Hospital
    Wuhan, Hubei 430030, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05472025
Lead sponsor
Tongji Hospital
Responsible party
Feng Gao (Director, Tongji Hospital) — Principal investigator
First posted
Jul 25, 2022
Start date
Oct 26, 2022 (estimated)
Primary completion
Apr 30, 2023 (estimated)
Completion
Apr 30, 2023 (estimated)
Last update
Oct 21, 2022

Study contacts

Feng Gao, Doctor
Contact
fgao@tjh.tjmu.edu.cn
8613971587381

Oversight

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

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This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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