Blood PressureNCT04469751
Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients
A study testing invasive blood pressure monitoring in people with Blood Pressure, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
Anesthesiologists need to understand the specific difference between dorsalis pedis arterial(DPA) pressure and the more commonly used radial arterial(RA) pressure When blood pressure monitoring at DPA. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- invasive blood pressure monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 30 May 2020
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who underwent neurosurgery,American Society of Anesthesiologists' physical status 1-3, BMI 18-24 kg/m², a clinical need for invasive arterial pressure monitoring in the supine position.
Who cannot join
- Arterial puncture site injury or infection,heart failure, severe arrhythmia, congenital heart disease, hypertension, diabetes,preoperative use of dehydration, and intracranial hypertension drugs such as mannitol, peripheral and macrovascular diseases, chronic lung disease, history of heart or lung surgery, The Allens test was positive.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients A Self-control Study
Anesthesiologists need to understand the specific difference between dorsalis pedis arterial(DPA) pressure and the more commonly used radial arterial(RA) pressure When blood pressure monitoring at DPA. Generally, the systolic blood pressure measured in DPA is significantly higher than that in RA, with little difference of diastolic blood pressure and mean artery pressure in two sites. However, there is no specific study on the difference between them, and it is not clear how the diagnosis and treatment threshold should be adjusted when relying on DPA blood pressure measurement to guide treatment. The intraoperative blood pressure of patients is in the normal range in most cases. The purpose of this study is to analyze the correlation of different blood pressure stratification (RASBP90-109mmHg,110-129mmHg,130-149mmHg) of DPA-RA in the normal range to understand the correlation of DPA-RA in different blood pressure ranges, to provide a reference for clinical decision-making and hemodynamic management.
- Conditions
- Blood Pressure
- Being tested
- invasive blood pressure monitoring
- Keywords
- correlation radial artery dorsalis pedis artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
invasive blood pressure monitoringDiagnostic test
radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing neurosurgery | Experimental | radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia Receives: Diagnostic Test: invasive blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
DPA-RA invasive blood pressure
All DPA-RA blood pressure dates are Separate analyzed in the following three intervals: Group1 (RASBP 90-109mmHg), Group1 (RASBP 110-129mmHg), Group1 (RASBP 130-149mmHg).The correlation and consistency of each group were analyzed
Measured: During anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Oct 2019
- Primary completion1 Mar 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469751
- Sponsor's protocol ID
- 2020-511
- Status last verified
- Jul 2020
- First submitted
- 5 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Y, Cui J, Sun JJ, Wang E, Zhu Y, Li Y, Lu K. Gradient between dorsalis pedis and radial arterial blood pressures during sevoflurane anaesthesia: A self-control study in patients undergoing neurosurgery. Eur J Anaesthesiol. 2016 Feb;33(2):110-7. doi: 10.1097/EJA.0000000000000295.
PubMed 26694940Chen Y, Wang E, Zhu Y, Li Y, Lu K. Dorsalis pedis arterial pressure is lower than noninvasive arm blood pressure in normotensive patients under sevoflurane anesthesia. Blood Press Monit. 2016 Feb;21(1):27-32. doi: 10.1097/MBP.0000000000000153.
PubMed 26484744
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients A Self-control Study
- ClinicalTrials.gov ID
- NCT04469751
- Acronym / sponsor ID
- 2020-511
- Conditions
- Blood Pressure
- Keywords
- correlation radial artery dorsalis pedis artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 14 Jul 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.
Anesthesiologists need to understand the specific difference between dorsalis pedis arterial(DPA) pressure and the more commonly used radial arterial(RA) pressure When blood pressure monitoring at DPA. Generally, the systolic blood pressure measured in DPA is significantly higher than that in RA, with little difference of diastolic blood pressure and mean artery pressure in two sites. However, there is no specific study on the difference between them, and it is not clear how the diagnosis and treatment threshold should be adjusted when relying on DPA blood pressure measurement to guide treatment. The intraoperative blood pressure of patients is in the normal range in most cases. The purpose of this study is to analyze the correlation of different blood pressure stratification (RASBP90-109mmHg,110-129mmHg,130-149mmHg) of DPA-RA in the normal range to understand the correlation of DPA-RA in different blood pressure ranges, to provide a reference for clinical decision-making and hemodynamic management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing neurosurgery | Experimental | Diagnostic Test: invasive blood pressure monitoringradial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who underwent neurosurgery,American Society of Anesthesiologists' physical status 1-3, BMI 18-24 kg/m², a clinical need for invasive arterial pressure monitoring in the supine position.
Key exclusion criteria (1 listed)
- Arterial puncture site injury or infection,heart failure, severe arrhythmia, congenital heart disease, hypertension, diabetes,preoperative use of dehydration, and intracranial hypertension drugs such as mannitol, peripheral and macrovascular diseases, chronic lung disease, history of heart or lung surgery, The Allens test was positive.
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 |
|---|---|---|
| invasive blood pressure monitoringradial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia | Diagnostic test | patients undergoing neurosurgery |
Primary outcome
DPA-RA invasive blood pressure
Time frame: During anesthesia induction
All DPA-RA blood pressure dates are Separate analyzed in the following three intervals: Group1 (RASBP 90-109mmHg), Group1 (RASBP 110-129mmHg), Group1 (RASBP 130-149mmHg).The correlation and consistency of each group were analyzed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Background: PubMed 26694940Chen Y, Cui J, Sun JJ, Wang E, Zhu Y, Li Y, Lu K. Gradient between dorsalis pedis and radial arterial blood pressures during sevoflurane anaesthesia: A self-control study in patients undergoing neurosurgery. Eur J Anaesthesiol. 2016 Feb;33(2):110-7. doi: 10.1097/EJA.0000000000000295.
- Background: PubMed 26484744Chen Y, Wang E, Zhu Y, Li Y, Lu K. Dorsalis pedis arterial pressure is lower than noninvasive arm blood pressure in normotensive patients under sevoflurane anesthesia. Blood Press Monit. 2016 Feb;21(1):27-32. doi: 10.1097/MBP.0000000000000153.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing invasive blood pressure monitoring in people with Blood Pressure, run by General Hospital of Ningxia Medical 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: finished, as of the sponsor's last update on 14 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DPA-RA invasive blood pressure (time frame: During anesthesia induction). 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 NCT04469751, which also lists 2 linked publications.
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 14 Jul 2020.