NCT04469751

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 5, 2020

Last Update Submit

July 11, 2020

Conditions

Keywords

correlation radial artery dorsalis pedis artery

Outcome Measures

Primary Outcomes (1)

  • 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

    During anesthesia induction

Study Arms (1)

patients undergoing neurosurgery

EXPERIMENTAL

radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia

Diagnostic Test: invasive blood pressure monitoring

Interventions

radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia

patients undergoing neurosurgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Related Publications (2)

  • 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.

    PMID: 26694940BACKGROUND
  • Chen 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.

    PMID: 26484744BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2020

First Posted

July 14, 2020

Study Start

October 1, 2019

Primary Completion

March 1, 2020

Study Completion

May 30, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations