- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379141
Ultrasonic Measurement of IVC and IJV in Predicting Hypotension After Anesthesia Induction
May 6, 2020 updated by: Jin Dong Liu
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
150
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients undergoing gastrointestinal surgery in the Affiliated Hospital of Xuzhou Medical University
Description
Inclusion Criteria:
- Gastrointestinal surgery
- BMI 18~24
- ASA score gradeⅠ~ III
Exclusion Criteria:
- anemia
- cirrhosis
- Emergency surgery
- severe hypertension
- New York Heart Association III ~ IV or ejection fraction <40%
- cirrhosis
- Other serious systemic diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
hypotension
Patients with hypotension after induction of anesthesia
|
non-hypotension
Patients without hypotension after induction of anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within 12 hours after anesthesia induction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasonic measurement of inferior vena cava and internal jugular vein
Time Frame: within 1 hour before anesthesia induction
|
Measure the maximum diameter, minimum diameter and cross-sectional area of inferior vena cava and internal jugular vein
|
within 1 hour before anesthesia induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jin Dong Liu, The Affiliated Hospital of Xuzhou Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 8, 2020
Primary Completion (Anticipated)
December 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
May 1, 2020
First Submitted That Met QC Criteria
May 6, 2020
First Posted (Actual)
May 7, 2020
Study Record Updates
Last Update Posted (Actual)
May 7, 2020
Last Update Submitted That Met QC Criteria
May 6, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XYFY2019-1202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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