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

Ultrasound Guidance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472025
• Other study ID #: TJ2022S073
• Status: Recruiting
• Start date: October 26, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2022
• Source: Tongji Hospital
• Contact: Feng Gao, Doctor
• Phone: 8613971587381
• Email: fgao[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Ultrasound Guidance

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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