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

NCT05472025 | Unknown DMC

• 1 other identifier: TJ2022S073
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Guidance

Keywords

ultrasound; carotid artery; inferior vena cava; hypotension

Outcome Measures

Primary Outcomes (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

  Before induction of anesthesia

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Patients who are scheduled to undergo surgery under general anesthesia
• Age ≥ 18 years old
• ASA I or II
• The patient is clearly conscious and has the ability to cooperate with the ultrasound measurement
• The patient signed the informed consent

You may not qualify if:

• Emergency surgery
• Consciousness disorder or mental disorder before surgery
• Sudden emergency vital sign changes before surgery, life-threatening patients
• Patients with preoperative respiratory distress, elevated intra-abdominal pressure, and expected difficult airway
• Patients with preoperative autonomic nervous system disease
• Patients with implantable pacemaker or cardioverter
• Patients with preoperative peripheral vascular disease, severe cardiovascular disease, unstable angina or cardiac ejection fraction less than 40%
• Pregnant women
• Carotid artery stenosis
• Severe carotid plaque

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Feng Gao, Doctor

CONTACT

8613971587381; fgao@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: October 26, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

CN (1)