- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06530901
Ultrasound of the Inferior Vena Cava in the Prevention of Hypotension After Induction of General Anesthesia
August 1, 2024 updated by: Zhuan Zhang
Multidimensional Ultrasound of the Inferior Vena Cava in the Prevention of Hypotension After Induction of General Anesthesia
Based on the preoperative ultrasound detection of various parametric indicators of the inferior vena cava cross-section, including the ratio of the inferior vena cava's long and short axes, cross-sectional area and circumference during two-dimensional and three-dimensional imaging, as well as the changes in respiratory variability of each parameter, we explored the predictive value of IVC ultrasound indicator parameters on hypotension after induction of general anesthesia in elderly patients undergoing elective non-cardiac surgery, screened the sensitive indicators, and calculated the cut-off values.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: zhuan zhang, professor
- Phone Number: +8615062791355
- Email: zhangzhuancg@163.com
Study Locations
-
-
Jiangsu
-
Yangzhou, Jiangsu, China
- the Affiliated Hospital of Yangzhou University, Yangzhou University
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Elderly patients undergoing elective non-cardiac surgery under general anesthesia
Description
Inclusion Criteria:
- Elderly patients undergoing elective non-cardiac surgery under general anesthesia;
- Age 65-85 years old;
- Body mass index (BMI) 18-28 kg/m2;
- American society of anesthesiologists (ASA) class I-III.
Exclusion Criteria:
- Patient refusal or lack of cooperation;
- Inability to communicate properly;
- Severe sinus bradycardia, pacemaker implantation, atrioventricular block, and atrial fibrillation;
- Presence of severe hepatic and renal function abnormalities;
- Preoperative cardiac ultrasound suggesting LVEF <50%;
- Tricuspid valve displacement <16 mm by preoperative cardiac ultrasound;
- Chronic obstructive pulmonary disease;
- Pulmonary hypertension;
- Administration of drugs that inhibit the renin-angiotensin-aldosterone system;
- Possibility of a difficult airway.
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 |
Intervention / Treatment |
|---|---|
|
Elderly patients undergoing elective noncardiac surgery under general anesthesia
|
Cross-sectional parameters of the inferior vena cava include two-dimensional longitudinal diameter, cross-sectional length and short diameter, circumference, and cross-sectional area, as well as cross-sectional length and short diameter, circumference, and cross-sectional area in three-dimensional imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the level of Mean Arterial Pressure
Time Frame: Baseline (before induction), 10 min after induction
|
The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction
|
Baseline (before induction), 10 min after induction
|
|
Changes in the level of Systolic Blood Pressure
Time Frame: Baseline (before induction), 10 min after induction
|
The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction
|
Baseline (before induction), 10 min after induction
|
|
Multidimensional ultrasound of the inferior vena cava
Time Frame: Baseline (before induction)
|
The outcome above should be measured at the time before induction
|
Baseline (before induction)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the level of Heart Rate
Time Frame: Baseline (before induction), 10 min after induction
|
The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction
|
Baseline (before induction), 10 min after induction
|
|
Changes in the level of Diastolic Blood Pressure
Time Frame: Baseline (before induction), 10 min after induction
|
The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction
|
Baseline (before induction), 10 min after induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: zhuan zhang, professor, The Affiliated Hospital of Yangzhou 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 (Estimated)
September 1, 2024
Primary Completion (Estimated)
March 31, 2025
Study Completion (Estimated)
March 31, 2025
Study Registration Dates
First Submitted
July 28, 2024
First Submitted That Met QC Criteria
July 28, 2024
First Posted (Actual)
July 31, 2024
Study Record Updates
Last Update Posted (Estimated)
August 5, 2024
Last Update Submitted That Met QC Criteria
August 1, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20240725
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.
Clinical Trials on Elderly Patients Undergoing Elective Non-cardiac Surgery
-
University of ZurichCompletedPatients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During SurgerySwitzerland
-
Imam Abdulrahman Bin Faisal UniversityJohns Hopkins Aramco HealthcareNot yet recruitingAdult Patients Undergoing Cardiac Surgery | High Bleeding Risks | Planned Elective Cardiac Surgery Using CPBSaudi Arabia
-
University of LuebeckCompletedPatients Undergoing Cardiac Surgery
-
Vanderbilt UniversityGE HealthcareCompletedPatients Undergoing Cardiac SurgeryUnited States
-
National Cancer Institute, NaplesActive, not recruitingPatients Undergoing Elective ColonoscopyItaly
-
Tokyo Women's Medical UniversityBaxter Healthcare CorporationUnknownPatients Undergoing Elective CraniotomyJapan
-
Pharmacosmos A/SCRO Max NeemanCompletedNon-anaemic Patients Undergoing Cardiac SurgeryDenmark
-
Minia UniversityMinia University HospitalCompletedPatients Undergoing Elective CraniotomyEgypt
-
University Hospital Inselspital, BerneCompletedPatients Undergoing Elective General AnesthesiaSwitzerland
-
University Hospital HeidelbergCompletedElective Non-cardiac SurgeryGermany
Clinical Trials on Multidimensional ultrasound of the inferior vena cava
-
University of LuebeckDeutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)Completed
-
Menoufia UniversityRecruiting
-
Assiut UniversityNot yet recruitingShock | Hypovolemia | Circulatory FailureEgypt
-
Teesside UniversityUnknownSepsis | Septic Shock | Severe SepsisUnited Kingdom
-
Assiut UniversityNot yet recruitingCentral Venous Pressure and Inferior Vena Cava Distensibility Index in Assessing Fluid Responsiveness in Septic Shocked Patients
-
Central Hospital, Nancy, FranceRecruiting
-
University of California, San DiegoUnited States Department of Defense; Emory University; University of Utah; Virginia...CompletedWounds and Injuries | TraumaUnited States
-
Derince Training and Research HospitalUnknownContrast-induced Nephropathy | Ileus; Mechanical
-
University of OklahomaCompleted
-
Derince Training and Research HospitalCompletedDehydration | Acute GastroenteritisTurkey