AnesthesiaNCT04379141
Ultrasonic Measurement of IVC and IJV in Predicting Hypotension After Anesthesia Induction
An observational study of Anesthesia, run by Jin Dong Liu.
Trial summary
This research is expected to study ultrasonic measurement of internal jugular vein and inferior vena cava, which can be used as a good index to predict hypotension after anesthesia induction, and its measurement method is simple and quick. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Anesthesia
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 8 May 2020to 30 Dec 2020
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing gastrointestinal surgery in the Affiliated Hospital of Xuzhou Medical University
Who may be able to join
- Gastrointestinal surgery
- BMI 18~24
- ASA score gradeⅠ~ III
Who cannot join
- anemia
- cirrhosis
- Emergency surgery
- severe hypertension
- New York Heart Association III ~ IV or ejection fraction <40%
- cirrhosis
- Other serious systemic diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasonic Measurement of Inferior Vena Cava and Internal Jugular Vein in Predicting Hypotension After Anesthesia Induction in Patients Undergoing Gastrointestinal Surgery
This research is expected to study ultrasonic measurement of internal jugular vein and inferior vena cava, which can be used as a good index to predict hypotension after anesthesia induction, and its measurement method is simple and quick.
Read the detailed description
The induction of anesthesia is the process from the physiological state to the anesthetic state in a short period of time. Hypotension after anesthesia induction is closely related to many organ injuries. Gastrointestinal surgery patients' prohibition of fasting is an important mechanism of severe hypotension after anesthesia induction. At present, ultrasonic measurement of inferior vena cava and internal jugular vein has been proved to be a convenient and non-invasive means to evaluate patients' blood volume. The purpose of this research was to study the relativity between ultrasonic measurement of inferior vena cava and internal jugular vein and hypotension after anesthesia induction in patients.
- Conditions
- Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hypotension | Patients with hypotension after induction of anesthesia | |
| non-hypotension | Patients without hypotension after induction of anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension after anesthesia Induction
Hypotension can be diagnosed if one of the following conditions is true: (1) a decrease in mean arterial pressure of > 20% compared to the baseline value (2) mean arterial pressure < 60mmHg
Measured: within 12 hours after anesthesia induction
Secondary outcomes (1)
Ultrasonic measurement of inferior vena cava and internal jugular vein
Measure the maximum diameter, minimum diameter and cross-sectional area of inferior vena cava and internal jugular vein
Measured: within 1 hour before anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start8 May 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Dong Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Dong Liu, Xuzhou Medical University
- Investigators
- Jin Dong Liu, Study director, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379141
- Sponsor's protocol ID
- XYFY2019-1202
- Status last verified
- May 2020
- First submitted
- 1 May 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Measurement of Inferior Vena Cava and Internal Jugular Vein in Predicting Hypotension After Anesthesia Induction in Patients Undergoing Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT04379141
- Acronym / sponsor ID
- XYFY2019-1202
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jin Dong LiuUniversity, hospital or other
- Study start
- 8 May 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 7 May 2020 (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.
This research is expected to study ultrasonic measurement of internal jugular vein and inferior vena cava, which can be used as a good index to predict hypotension after anesthesia induction, and its measurement method is simple and quick.
Detailed description
The induction of anesthesia is the process from the physiological state to the anesthetic state in a short period of time. Hypotension after anesthesia induction is closely related to many organ injuries. Gastrointestinal surgery patients' prohibition of fasting is an important mechanism of severe hypotension after anesthesia induction. At present, ultrasonic measurement of inferior vena cava and internal jugular vein has been proved to be a convenient and non-invasive means to evaluate patients' blood volume. The purpose of this research was to study the relativity between ultrasonic measurement of inferior vena cava and internal jugular vein and hypotension after anesthesia induction in patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypotension | – | –Patients with hypotension after induction of anesthesia |
| non-hypotension | – | –Patients without hypotension after induction of anesthesia |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing gastrointestinal surgery in the Affiliated Hospital of Xuzhou Medical University
Key inclusion criteria (3 listed)
- Gastrointestinal surgery
- BMI 18~24
- ASA score gradeⅠ~ III
Key exclusion criteria (7 listed)
- anemia
- cirrhosis
- Emergency surgery
- severe hypertension
- New York Heart Association III ~ IV or ejection fraction <40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hypotension after anesthesia Induction
Time frame: within 12 hours after anesthesia induction
Hypotension can be diagnosed if one of the following conditions is true: (1) a decrease in mean arterial pressure of > 20% compared to the baseline value (2) mean arterial pressure < 60mmHg
1 secondary outcome
Ultrasonic measurement of inferior vena cava and internal jugular vein
Time frame: within 1 hour before anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
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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.
Jin Dong Liu study director
The Affiliated Hospital of Xuzhou Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Jin Dong Liu.
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 3 inclusion and 7 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jin Dong Liu, M.S (+86-13951355136, liujindong1818@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension after anesthesia Induction (time frame: within 12 hours after anesthesia induction). 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 7 May 2020.