Specific GravityNCT05644535
Cerebrospinal Fluid Gravity Correlation Analysis
An observational study of Specific Gravity and Cerebrospinal Fluid, run by First People's Hospital of Chenzhou at 1 site in China.
Trial summary
The purpose of this study was to measure cerebrospinal fluid density in aged patients and to see if there was a correlation between these factors and cerebrospinal fluid density by using the electronic medical record system to understand the patient's gender, blood glucose, blood biochemical electrolytes and blood… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Specific Gravity, Cerebrospinal Fluid
- What is being tested?
- Cerebrospinal fluid densitometry, blood routine examination and Blood electrolyte examination
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 May 2023
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Selected aged patients who had hip arthroplasty in our hospital between December 2022 and May 2023
Who may be able to join
- Receiving combined spinal and epidural anesthesia or subarachnoid anesthesia ASA Ⅰ or Ⅱ patients No significant neurological pathology No recent history of cerebral infarction No recent history of cerebral hemorrhage No central nervous system inflammation No spinal inflammatory disease No history of spinal surgery Patients who have given pre-operative informed written consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Zhiming Zhang
Chenzhou, Hunan, 423000
Zhiming Zhang, M.D., +8613875555649, otc0735@163.com
About this study
Official title: Correlation Between Blood Biochemical Indicators and Cerebrospinal Fluid Gravity in Aged Patients
The purpose of this study was to measure cerebrospinal fluid density in aged patients and to see if there was a correlation between these factors and cerebrospinal fluid density by using the electronic medical record system to understand the patient's gender, blood glucose, blood biochemical electrolytes and blood levels.
Read the detailed description
Hip joint injury is one of the common injuries in the elderly, and hip arthroplasty is a treatment method that allows patients to get out of bed and return to social life as soon as possible. Currently, the common position for hip arthroplasty is the lateral position; and combined spinal and epidural anesthesia or subarachnoid anesthesia is also the common anesthesia method for hip arthroplasty. In the lateral position, the patient's affected limb is often on top and the healthy limb is on the bottom; the healthy side position is also the usual position for hip arthroplasty. In this position, it may be optimal to use a lighter specific gravity local anesthetic drug because it tends to anesthetize only the upper affected limb and does not require a return to the supine position after anesthesia due to changes in the plane of block, minimizing pain and hemodynamic fluctuations during anesthesia and position changes.
Currently, light specific gravity is more of a concept. Because in the available data, only the range of cerebrospinal fluid density of ordinary healthy adults is available, there is little literature and data to describe and analyze what the cerebrospinal fluid density of elderly patients actually is. Therefore, when we administer subarachnoid anesthesia to elderly patients, we cannot determine whether the dispensed local anesthetic drug is a light specific gravity.
In this study, we intend to collect cerebrospinal fluid from elderly patients who underwent hip arthroplasty under combined lumbar and rigid anesthesia or subarachnoid anesthesia, and measure the cerebrospinal fluid density in elderly patients, and observe whether there is a correlation between the above factors and cerebrospinal fluid density through the electronic medical record system to understand the patient's gender, blood glucose, blood biochemical electrolytes and routine blood levels; thus, we can better guide the use of lighter specific gravity drugs in clinical practice.
- Conditions
- Specific Gravity, Cerebrospinal Fluid
- Being tested
- Cerebrospinal fluid densitometry, blood routine examination, Blood electrolyte examination
- Keywords
- Cerebrospinal fluid, Correlation Analysis, Lighter Specific Gravity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrospinal fluid densitometryDiagnostic test
After obtaining the patient's cerebrospinal fluid specimen, the actual mass of the cerebrospinal fluid was measured by pipetting 1000 μL of cerebrospinal fluid specimen on an analytical balance using a pipette gun, and all specimens were measured three times and the average of the three times was taken as the final mass of 1000 μL of that specimen. After the mass measurement, the residual cerebrospinal fluid was disposed of as medical waste. The density of each specimen was obtained according to the density to mass conversion formula ρ=m/v.
blood routine examinationDiagnostic test
After obtaining the patient's blood specimens, they were sent to the laboratory for blood routine examination.
Blood electrolyte examinationDiagnostic test
After obtaining the patient's blood specimens, they were sent to the laboratory for blood electrolyte examination.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients were aged 60-69 years Receives: Diagnostic Test: Cerebrospinal fluid densitometry; Diagnostic Test: blood routine examination; Diagnostic Test: Blood electrolyte examination | |
| Group B | Patients were aged 70-79 years Receives: Diagnostic Test: Cerebrospinal fluid densitometry; Diagnostic Test: blood routine examination; Diagnostic Test: Blood electrolyte examination | |
| Group C | Patients were aged 80-89 years Receives: Diagnostic Test: Cerebrospinal fluid densitometry; Diagnostic Test: blood routine examination; Diagnostic Test: Blood electrolyte examination | |
| Group D | Patient age > 90 years Receives: Diagnostic Test: Cerebrospinal fluid densitometry; Diagnostic Test: blood routine examination; Diagnostic Test: Blood electrolyte examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrospinal fluid density
After obtaining the mass of cerebrospinal fluid, the density was calculated from ρ=m/v
Measured: baseline (before anesthesia)
Secondary outcomes (7)
Blood sugar
Plasma glucose level
Measured: baseline (before anesthesia)
Plasma K+ concentration
Plasma K+ concentration
Measured: baseline (before anesthesia)
Plasma Cl- concentration
Plasma Cl- concentration
Measured: baseline (before anesthesia)
WBC
Leukocyte concentration in blood
Measured: baseline (before anesthesia)
Neutrophil concentration in blood
Neutrophil concentration in blood
Measured: baseline (before anesthesia)
Lymphocyte concentration in blood
Lymphocyte concentration in blood
Measured: baseline (before anesthesia)
C-reactive protein (CRP)
C-reactive protein concentration in plasma
Measured: baseline (before anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific GravityStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhiming zhang, First People's Hospital of Chenzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644535
- Sponsor's protocol ID
- 202201
- Status last verified
- Nov 2022
- First submitted
- 1 Dec 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Blood Biochemical Indicators and Cerebrospinal Fluid Gravity in Aged Patients
- ClinicalTrials.gov ID
- NCT05644535
- Acronym / sponsor ID
- 202201
- Conditions
- Specific Gravity, Cerebrospinal Fluid
- Keywords
- Cerebrospinal fluid, Correlation Analysis, Lighter Specific Gravity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 9 Dec 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.
The purpose of this study was to measure cerebrospinal fluid density in aged patients and to see if there was a correlation between these factors and cerebrospinal fluid density by using the electronic medical record system to understand the patient's gender, blood glucose, blood biochemical electrolytes and blood levels.
Detailed description
Hip joint injury is one of the common injuries in the elderly, and hip arthroplasty is a treatment method that allows patients to get out of bed and return to social life as soon as possible. Currently, the common position for hip arthroplasty is the lateral position; and combined spinal and epidural anesthesia or subarachnoid anesthesia is also the common anesthesia method for hip arthroplasty. In the lateral position, the patient's affected limb is often on top and the healthy limb is on the bottom; the healthy side position is also the usual position for hip arthroplasty. In this position, it may be optimal to use a lighter specific gravity local anesthetic drug because it tends to anesthetize only the upper affected limb and does not require a return to the supine position after anesthesia due to changes in the plane of block, minimizing pain and hemodynamic fluctuations during anesthesia and position changes.
Currently, light specific gravity is more of a concept. Because in the available data, only the range of cerebrospinal fluid density of ordinary healthy adults is available, there is little literature and data to describe and analyze what the cerebrospinal fluid density of elderly patients actually is. Therefore, when we administer subarachnoid anesthesia to elderly patients, we cannot determine whether the dispensed local anesthetic drug is a light specific gravity.
In this study, we intend to collect cerebrospinal fluid from elderly patients who underwent hip arthroplasty under combined lumbar and rigid anesthesia or subarachnoid anesthesia, and measure the cerebrospinal fluid density in elderly patients, and observe whether there is a correlation between the above factors and cerebrospinal fluid density through the electronic medical record system to understand the patient's gender, blood glucose, blood biochemical electrolytes and routine blood levels; thus, we can better guide the use of lighter specific gravity drugs in clinical practice.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: Cerebrospinal fluid densitometry, Diagnostic Test: blood routine examination, Diagnostic Test: Blood electrolyte examinationPatients were aged 60-69 years |
| Group B | – | Diagnostic Test: Cerebrospinal fluid densitometry, Diagnostic Test: blood routine examination, Diagnostic Test: Blood electrolyte examinationPatients were aged 70-79 years |
| Group C | – | Diagnostic Test: Cerebrospinal fluid densitometry, Diagnostic Test: blood routine examination, Diagnostic Test: Blood electrolyte examinationPatients were aged 80-89 years |
| Group D | – | Diagnostic Test: Cerebrospinal fluid densitometry, Diagnostic Test: blood routine examination, Diagnostic Test: Blood electrolyte examinationPatient age > 90 years |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Selected aged patients who had hip arthroplasty in our hospital between December 2022 and May 2023
Key inclusion criteria (1 listed)
- Receiving combined spinal and epidural anesthesia or subarachnoid anesthesia ASA Ⅰ or Ⅱ patients No significant neurological pathology No recent history of cerebral infarction No recent history of cerebral hemorrhage No central nervous system inflammation No spinal inflammatory disease No history of spinal surgery Patients who have given pre-operative informed written consent
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Cerebrospinal fluid densitometryAfter obtaining the patient's cerebrospinal fluid specimen, the actual mass of the cerebrospinal fluid was measured by pipetting 1000 μL of cerebrospinal fluid specimen on an analytical balance using a pipette gun, and all specimens were measured three times and the average of the three times was taken as the final mass of 1000 μL of that specimen. After the mass measurement, the residual cerebrospinal fluid was disposed of as medical waste. The density of each specimen was obtained according to the density to mass conversion formula ρ=m/v. | Diagnostic test | Group A, Group B, Group C, Group D |
| blood routine examinationAfter obtaining the patient's blood specimens, they were sent to the laboratory for blood routine examination. | Diagnostic test | Group A, Group B, Group C, Group D |
| Blood electrolyte examinationAfter obtaining the patient's blood specimens, they were sent to the laboratory for blood electrolyte examination. | Diagnostic test | Group A, Group B, Group C, Group D |
Primary outcome
Cerebrospinal fluid density
Time frame: baseline (before anesthesia)
After obtaining the mass of cerebrospinal fluid, the density was calculated from ρ=m/v
7 secondary outcomes
Blood sugar
Time frame: baseline (before anesthesia)
Plasma K+ concentration
Time frame: baseline (before anesthesia)
Plasma Cl- concentration
Time frame: baseline (before anesthesia)
WBC
Time frame: baseline (before anesthesia)
Neutrophil concentration in blood
Time frame: baseline (before anesthesia)
Lymphocyte concentration in blood
Time frame: baseline (before anesthesia)
C-reactive protein (CRP)
Time frame: baseline (before anesthesia)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 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 Specific Gravity and Cerebrospinal Fluid, run by First People's Hospital of Chenzhou 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 9 Dec 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 Zhiming Zhang (+8613875555649, otc0735@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrospinal fluid density (time frame: baseline (before anesthesia)). 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 9 Dec 2022.