Predicting If the Blood Pressure Will Drop After Spinal Anesthesia Using Ultrasound of the Neck

November 28, 2024 updated by: Joris Van Houte, Catharina Ziekenhuis Eindhoven

Prediction of Hypotension After Spinal Anesthesia by Doppler Measurement of the Corrected Carotid Flow Time and the Peak Velocity Variation Within the Common Carotid Artery

After a spinal injection, blood pressure might drop for a short time, similar to what happens with general anesthesia. This drop can be different for each person. An anesthesiologist will use medicine to bring the blood pressure back to normal. If this drop could be predicted in advance, it would help the anesthesiologist treat it faster, making the procedure even safer and preventing side effects like dizziness or nausea.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

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

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
        • Catharina Ziekenhuis

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients scheduled for elective surgery under spinal anesthesia.

Description

Inclusion Criteria:

  • Adult patients of either sex who are scheduled for elective surgery under spinal anesthesia,
  • Who fasted for 6 hours or more

Exclusion Criteria:

  • Age <18 years old
  • No informed consent for study participation
  • Contra-indication for spinal anesthesia
  • Emergency surgery
  • Known poor left or right ventricular function / heart failure
  • Moderate to severe valvular disease
  • Atrial fibrillation
  • Pacemaker rhythm
  • Carotid artery stenosis > 50%
  • History of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  • History of cerebral trauma
  • Pregnancy
  • Neck complaints
  • Morbid obesity (BMI > 40 kg/m2)

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Hypotensive patients
Patients who developed hypotension after the induction of spinal anesthesia.
Diagnostic test: Carotid ultrasound measurement
Pulsed-wave Doppler acquisition of the carotid artery. One acquisition will be made with the slow-speed setting (33 mm/s) and one with the medium-speed setting (66 mm/s).
Diagnostic test: Vital sign measurement
Measurement of noninvasive blood pressure, at different time points before and after the induction of spinal anesthesia.
Drug: Spinal anesthesia
Following the standard of care, the patients received spinal anesthesia. The type and dosage of the local anesthetic were at the discretion of the treating anesthesiologist.
Normotensive patients
Patients who did not develop hypotension after the induction of spinal anesthesia.
Diagnostic test: Carotid ultrasound measurement
Pulsed-wave Doppler acquisition of the carotid artery. One acquisition will be made with the slow-speed setting (33 mm/s) and one with the medium-speed setting (66 mm/s).
Diagnostic test: Vital sign measurement
Measurement of noninvasive blood pressure, at different time points before and after the induction of spinal anesthesia.
Drug: Spinal anesthesia
Following the standard of care, the patients received spinal anesthesia. The type and dosage of the local anesthetic were at the discretion of the treating anesthesiologist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine the predictive value of pre-anesthetic carotid parameters to predict spinal anesthesia-induced hypotension.
Time Frame: Prior to surgery.
To determine the predictive value of pre-anesthetic corrected carotid flow time (ccFT) and peak velocity variation values for hypotension after induction of spinal anesthesia.
Prior to surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between carotid parameters and blood pressure.
Time Frame: Trough study completion, an average of 30 minutes.
To determine the correlation between the pre-anesthetic corrected carotid flow time (ccFT) and peak velocity variation on one hand and the maximal changes in systolic and mean arterial blood pressure after spinal anesthesia on the other hand.
Trough study completion, an average of 30 minutes.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intra-observer and inter-observer reproducibility of carotid Doppler parameters.
Time Frame: Prior to surgery.
To determine the intra-observer and inter-observer reproducibility of Doppler parameters derived by two experienced sonographers.
Prior to surgery.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catharina Ziekenhuis Eindhoven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Arthur Bouwman, Professor, Catharina Ziekenhuis

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

  • J. van Houte. The corrected carotid artery flow time and carotid peak velocity variation do not predict spinal anesthesia-induced hypotension: A prospective observational study. JCA Advances. 2024; 1: 1-8.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W22.234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patients did not give consent that their data would be used in studies other than spinal anesthesia-induced hypotension prediction.

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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