Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area for Prediction of Post Spinal Hypotension

July 22, 2021 updated by: Walid Nofal, Ain Shams University

Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area for Prediction of Post Spinal Hypotension in Patients Undergoing Orthopedic Surgeries

The aim of this study is to evaluate the efficacy of internal jugular cross sectional area for predicting the occurrence of PSAH.

Study Overview

Detailed Description

The aim of this study is to evaluate the efficacy of internal jugular cross sectional area for predicting the occurrence of PSAH. Spinal anaesthesia is frequently used in daily clinical practice. Postspinal anaesthesia hypotension (PSAH) is a common side effect with an incidence of 15.3 to 33% that may result in organ hypoperfusion and ischaemic events. Patients' susceptibility to intraoperative hypotension can be influenced by the sensory block level, age, preoperative volume status , physical status, pre-operative medications and fasting.

PSAH due to spinal blockade is principally a consequence of diminished systemic vascular resistance after blockade of preganglionic sympathetic fibres. Many attempts have been tried to prevent PSAH, such as intravenous volume preload or prophylactic vasopressors. However, fluid infusion has been proved to lower the incidence of PSAH and significantly decrease vasopressor requirements. At the same time, empirical volume loading carries the potential of volume overload, particularly in patients with cardiac disease. Consequently, the search for predictors of PSAH is becoming mandatory to avoid blind volume loading and reserve it only for patients who are expected to develop PSAH. .

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Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • القاهرة
      • Cairo, القاهرة, Egypt
        • Ain Shams University Hospital

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients more than 40 years of age with American Society of Anesthesiologists' (ASA) physical status 1 or 2 who will be scheduled for elective orthopedic surgery under spinal anaesthesia in the supine position

Description

Inclusion Criteria:

  • patients more than 40 years of age.
  • American Society of Anesthesiologists' (ASA) physical status 1 or 2.
  • scheduled for elective surgery under spinal anaesthesia in the supine position.

Exclusion Criteria:

  • BMI more than 35 kg m2.
  • taking angiotensin converting enzyme inhibitors.
  • pregnant women.
  • emergency cases.
  • absolute or relative contraindications to spinal anaesthesia.
  • Also, patients with a baseline arterial systolic blood pressure less than 90 mmHg or mean arterial blood pressure (MBP) less than 70 mmHg will be excluded.

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

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value of internal jugular vein (IJV) cross sectional area.
Time Frame: 30 minutes
The primary outcome is to evaluate the predictive value of internal jugular diameter cross sectional area for detecting PSAH
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sanaa Farag Mahmoud, MD, Anesthesiology department, Faculty of Medicine, Ain Shams University
  • Principal Investigator: Eman Sabek, MD, Radiology department, National Centre of Radiation Research and Technology, Atomic Energy Authority
  • Principal Investigator: WALID Nofal, MD, Anesthesiology department, Faculty of Medicine, Ain Shams Unive

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 (Actual)

March 1, 2021

Primary Completion (Actual)

July 21, 2021

Study Completion (Actual)

July 21, 2021

Study Registration Dates

First Submitted

February 28, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 25/2020/2021

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

product manufactured in and exported from the U.S.

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.

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