Hemodynamic Management in Women With SHS

March 3, 2023 updated by: Yuqing Li, China Medical University, China

Hemodynamic Management Target on Continuous Monitoring in Cesarean Delivery-A Randomized Controlled Trial in Patients With Supine Hypotensive Syndrome

Supine hypotensive syndrome often occurs following spinal anesthesia for cesarean delivery.In our study we base the regulation and drug administration both on the regular monitor and on a novel monitor which reflects upon the hemodynamic changes. Our aim is to observe whether the outcome of SHS patients with anesthesia management based on hemodynamic figures differs from those based on experience.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • China Medical University
        • Contact:
          • Li Yuqing
          • Phone Number: 86-15942019671

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

22 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) Physical Status Classification II and had no significant cardiovascular, pulmonary, renal or endocrine disease, without contraindications to CSEA,and could be diagnosed as SHS according to the criteria.

Exclusion Criteria:

  • Patients undergoing emergency CD, CD under general anesthesia or patients' refusal to participate, or multiple fetations.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Blank Group
In this group, the anesthesia management is conducted according to the anesthetists' experience, based on the regular monitor.
Experimental: LiDCOrapid Group
In this group, the anesthesia management is conducted based on both the regular monitor and the hemodynamic figures on the LiDCOrapid.
Procedure: LiDCOrapid
According to the illustration of the patient's hemodynamic figures shown on the LiDCOrapid monitor, we decide on the timing of the vasopressor administration. This group aims to maintain the cardiac output within a baseline range.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical arterial blood gas PH
Time Frame: 30minutes
The value is tested immediately after the blood sample is achieved after the infant is born.
30minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discomfort Score
Time Frame: 1day
we explored a scoring system to quantify the SHS symptom scale from 0 to 8, score high means more symptoms of SHS occurred
1day
total vasopressor dosage
Time Frame: 30 minutes
total vasopressor given during the time span between the operation began to the baby was delivered
30 minutes
Umbilical blood gas lactate
Time Frame: 30minutes
The value is tested immediately after the blood sample is achieved after the infant is born.
30minutes
Time span
Time Frame: 2 hours
the period between the operation began to the baby was delivered
2 hours

Collaborators and Investigators

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

Sponsor

China Medical University, China

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)

April 17, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

April 10, 2022

First Submitted That Met QC Criteria

April 16, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHSandLidco

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Supine Hypotensive Syndrome

Clinical Trials on LiDCOrapid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe