(∆PI) to Predict Post-spinal Anesthesia Hypotension

November 2, 2024 updated by: Mina Adolf Helmy, Cairo University

The Change in Femoral Artery Pulsatility Index as a Novel Predictor to Post-spinal Hypotension in Adult Patient Undergoing Infraumbilical Surgeries, a Prospective Observational Study

we aimed to evaluate the change in femoral artery pulsatility index as a predictor to post-spinal anesthesia hypotension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After spinal anesthesia, hypotension is a common effect that occurs in between 15 and 30% of patients therefore it is essential to prevent such effect.

number of variables were utilized for estimating post spinal hypotension, such as assessing heart rate variability, perfusion index, inferior vena cava collapsibility index; however, the majority of these indices needs advanced equipment.

investigator of current research decided to study the role of ultrasound derived index namely pulsatility index to predict post spinal anesthesia hypotension.

Study Type

Observational

Enrollment (Actual)

54

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

  • Egypt
      • Cairo, Egypt
        • Cairo university

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patient undergoing spinal anesthesia for infra-umbilical surgeries

Description

Inclusion Criteria:

  • adult patient undergoing infra-umbilical surgeries.

Exclusion Criteria:

  • coagulopathy peripheral vascular disease contraindication to spinal anesthesia

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in pulsatility index to predict post spinal anesthesia induced hypotension
Time Frame: baseline and immediately after spinal anesthesia
to measure PI before and after spinal anesthesia
baseline and immediately after spinal anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in resistive index to predict post spinal anesthesia induced hypotension
Time Frame: baseline and immediately after spinal anesthesia
to measure RI before and after spinal anesthesia
baseline and immediately after spinal anesthesia
change in waveform morphology to predict post spinal hypotension
Time Frame: before and immediately after spinal anesthesia
change of waveform morphology before and after spinal anesthesia
before and immediately after spinal anesthesia

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 31, 2024

Primary Completion (Actual)

October 20, 2024

Study Completion (Actual)

October 20, 2024

Study Registration Dates

First Submitted

June 29, 2024

First Submitted That Met QC Criteria

July 5, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 2, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (∆PI) in spinal hypotension

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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