Ultrasound GuidanceNCT05472025
Clinical Study of Combined Carotid Artery With Inferior Vena Cava Ultrasonography to Predict Hypotension After Induction of General Anesthesia
An observational study of Ultrasound Guidance, run by Tongji Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ultrasound Guidance
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Conscious adult patients with normal intra-abdominal pressure; no patients with severe diabetes, no severe carotid stenosis and plaque
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Feng Gao, Doctor, 8613971587381, fgao@tjh.tjmu.edu.cn
About this study
Official title: Clinical Study of Combined Carotid Artery With Inferior Vena Cava Ultrasonography to Predict Hypotension After Induction of General Anesthesia: a Prospective Study
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.
- Conditions
- Ultrasound Guidance
- Keywords
- ultrasound, carotid artery, inferior vena cava, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: after induction of anesthesia tracheal intubation 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start26 Oct 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound GuidanceStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472025
- Sponsor's protocol ID
- TJ2022S073
- Status last verified
- Oct 2022
- First submitted
- 21 Jul 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Combined Carotid Artery With Inferior Vena Cava Ultrasonography to Predict Hypotension After Induction of General Anesthesia: a Prospective Study
- ClinicalTrials.gov ID
- NCT05472025
- Acronym / sponsor ID
- TJ2022S073
- Conditions
- Ultrasound Guidance
- Keywords
- ultrasound, carotid artery, inferior vena cava, hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 26 Oct 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Conscious adult patients with normal intra-abdominal pressure; no patients with severe diabetes, no severe carotid stenosis and plaque
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | Changes in blood pressure |
Primary outcome
Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Guidance, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Gao, Doctor (8613971587381, fgao@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive power of the post-induced hypotension of combined carotid artery sonography with inferior vena cava sonography (time frame: Before induction of anesthesia). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.