HemodynamicNCT06641505
Feasibility of Deep Inspiratory Internal Jugular Vein Variability in Guiding Preoperative Fluid Replacement
A study testing Guiding rehydration in people with Hemodynamic, run by Affiliated Hospital of Jiaxing University at 1 site in China.
Trial summary
Compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction, so as to evaluate the feasibility of using the internal jugular… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hemodynamic
- What is being tested?
- Guiding rehydration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 1 Jun 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 60 years； American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ； Surgery with radial artery puncture； Propofol induction；
Who cannot join
- BMI≥30kg/m2； People with short necks； Previous hypotension (systolic blood pressure <90mmHg or mean arterial pressure<65mmHg)； Previous poorly controlled hypertension； Cardiac insufficiency , EF value<50%； Upper limb deep vein thrombosis； History of radiotherapy or neck surgery； Inability to maintain a supine position for necessary measurements； Mechanical ventilation status or inability to take deep breaths patients； gastrointestinal surgery； Patients allergic to propofol； Restricted fluid intake；
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of University
Jiaxing, Zhejiang
Qinghe Zhou, 13732573379, jxxmxy@163.com
About this study
Official title: Feasibility of Deep Inspiratory Internal Jugular Vein Variability in Guiding Preoperative Fluid Replacement：A Prospective, Randomized Controlled Study
Compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction, so as to evaluate the feasibility of using the internal jugular vein variability under deep inspiration to guide preoperative fluid infusion.
Read the detailed description
Ultrasound records at least one quiet breathing cycle and one deep inhalation cycle to calculate IJVV Propofol was infused target-controlled at 4 μg/ml, and changes in arterial blood pressure within 3 minutes of propofol induction were observed.
Plan to conduct a prospective randomized controlled study to compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction.
- Conditions
- Hemodynamic
- Being tested
- Guiding rehydration
- Keywords
- Internal jugular vein, propofol, hemodynamic, hypotension, fluid replacement
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guiding rehydrationBehavioural
Preoperative fluid rehydration was performed according to 421 fluid rehydration principles
| Study group | Role | What they receive |
|---|---|---|
| Guiding rehydration group | Experimental | According to the 421 fluid replacement principle, preoperative fluid replacement is performed Receives: Behavioral: Guiding rehydration |
| Conventional rehydration group | Active comparator | rehydrated within 15 minutes according to 0.2ml/kg/min. Receives: Behavioral: Guiding rehydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of a 20% drop in blood pressure after propofol induction
The incidence of a 20% drop in blood pressure after propofol induction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Aug 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodynamicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-he Zhou, Affiliated Hospital of Jiaxing University
- Investigators
- Qinghe Zhou, Principal investigator, Affiliated Hospital of Jiaxing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641505
- Sponsor's protocol ID
- 2024-KY-520
- Status last verified
- Aug 2024
- First submitted
- 12 Oct 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei XL, Xi YZ, Xie L, Li ZP, Tang HL, Zhou QH. Effects of liquid resuscitation guided by internal jugular vein variability during deep inhalation on preventing propofol-induced hypotension in elderly patients. BMC Anesthesiol. 2025 Jul 17;25(1):350. doi: 10.1186/s12871-025-03227-3.
PubMed 40676549
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Deep Inspiratory Internal Jugular Vein Variability in Guiding Preoperative Fluid Replacement：A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06641505
- Acronym / sponsor ID
- 2024-KY-520
- Conditions
- Hemodynamic
- Keywords
- Internal jugular vein, propofol, hemodynamic, hypotension, fluid replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
Compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction, so as to evaluate the feasibility of using the internal jugular vein variability under deep inspiration to guide preoperative fluid infusion.
Detailed description
Ultrasound records at least one quiet breathing cycle and one deep inhalation cycle to calculate IJVV Propofol was infused target-controlled at 4 μg/ml, and changes in arterial blood pressure within 3 minutes of propofol induction were observed.
Plan to conduct a prospective randomized controlled study to compare the incidence of hypotension during the propofol-induced period between the internal jugular vein variability-guided fluid infusion group and the conventional fluid infusion group through a fluid infusion experiment before anesthesia induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guiding rehydration group | Experimental | Behavioral: Guiding rehydrationAccording to the 421 fluid replacement principle, preoperative fluid replacement is performed |
| Conventional rehydration group | Active comparator | Behavioral: Guiding rehydrationrehydrated within 15 minutes according to 0.2ml/kg/min. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age over 60 years； American Society of Anesthesiology (ASA) status Ⅱ-Ⅲ； Surgery with radial artery puncture； Propofol induction；
Key exclusion criteria (1 listed)
- BMI≥30kg/m2； People with short necks； Previous hypotension (systolic blood pressure <90mmHg or mean arterial pressure<65mmHg)； Previous poorly controlled hypertension； Cardiac insufficiency , EF value<50%； Upper limb deep vein thrombosis； History of radiotherapy or neck surgery； Inability to maintain a supine position for necessary measurements； Mechanical ventilation status or inability to take deep breaths patients； gastrointestinal surgery； Patients allergic to propofol； Restricted fluid intake；
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 |
|---|---|---|
| Guiding rehydrationPreoperative fluid rehydration was performed according to 421 fluid rehydration principles | Behavioural | Conventional rehydration group, Guiding rehydration group |
Primary outcome
The incidence of a 20% drop in blood pressure after propofol induction
Time frame: 1 year
The incidence of a 20% drop in blood pressure after propofol induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Derived from this study: PubMed 40676549Wei XL, Xi YZ, Xie L, Li ZP, Tang HL, Zhou QH. Effects of liquid resuscitation guided by internal jugular vein variability during deep inhalation on preventing propofol-induced hypotension in elderly patients. BMC Anesthesiol. 2025 Jul 17;25(1):350. doi: 10.1186/s12871-025-03227-3.
- 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.
Qinghe Zhou principal investigator
Affiliated Hospital of Jiaxing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guiding rehydration in people with Hemodynamic, run by Affiliated Hospital of Jiaxing University 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 1 inclusion and 1 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 15 Nov 2024. 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 Qinghe Zhou (13732573379, jxxmxy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of a 20% drop in blood pressure after propofol induction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06641505, which also lists 1 linked publication.
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 15 Nov 2024.