Back to resultsHemodynamic Management in Women With SHS
Primary Purpose
Supine Hypotensive Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LiDCOrapid
Sponsored by
About this trial
This is an interventional prevention trial for Supine Hypotensive Syndrome focused on measuring supine hypotensive syndrome, cesarean delivery, spinal anesthesia, CSEA
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologist (ASA) Physical Status Classification II and had no significant cardiovascular, pulmonary, renal or endocrine disease, 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.
Sites / Locations
- China Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Blank Group
LiDCOrapid Group
Arm Description
In this group, the anesthesia management is conducted according to the anesthetists' experience, based on the regular monitor.
In this group, the anesthesia management is conducted based on both the regular monitor and the hemodynamic figures on the LiDCOrapid.
Outcomes
Primary Outcome Measures
Umbilical arterial blood gas PH
The value is tested immediately after the blood sample is achieved after the infant is born.
Secondary Outcome Measures
Discomfort Score
we explored a scoring system to quantify the SHS symptom scale from 0 to 8, score high means more symptoms of SHS occurred
total vasopressor dosage
total vasopressor given during the time span between the operation began to the baby was delivered
Umbilical blood gas lactate
The value is tested immediately after the blood sample is achieved after the infant is born.
Time span
the period between the operation began to the baby was delivered
Full Information
NCT ID
NCT05341362
First Posted
April 10, 2022
Last Updated
March 3, 2023
Sponsor
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT05341362
Brief Title
Hemodynamic Management in Women With SHS
Official Title
Hemodynamic Management Target on Continuous Monitoring in Cesarean Delivery-A Randomized Controlled Trial in Patients With Supine Hypotensive Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supine Hypotensive Syndrome
Keywords
supine hypotensive syndrome, cesarean delivery, spinal anesthesia, CSEA
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blank Group
Arm Type
No Intervention
Arm Description
In this group, the anesthesia management is conducted according to the anesthetists' experience, based on the regular monitor.
Arm Title
LiDCOrapid Group
Arm Type
Experimental
Arm Description
In this group, the anesthesia management is conducted based on both the regular monitor and the hemodynamic figures on the LiDCOrapid.
Intervention Type
Procedure
Intervention Name(s)
LiDCOrapid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Umbilical arterial blood gas PH
Description
The value is tested immediately after the blood sample is achieved after the infant is born.
Time Frame
30minutes
Secondary Outcome Measure Information:
Title
Discomfort Score
Description
we explored a scoring system to quantify the SHS symptom scale from 0 to 8, score high means more symptoms of SHS occurred
Time Frame
1day
Title
total vasopressor dosage
Description
total vasopressor given during the time span between the operation began to the baby was delivered
Time Frame
30 minutes
Title
Umbilical blood gas lactate
Description
The value is tested immediately after the blood sample is achieved after the infant is born.
Time Frame
30minutes
Title
Time span
Description
the period between the operation began to the baby was delivered
Time Frame
2 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The disease supine hypotensive syndrome happens among pregnant women in their late pregnancy. Therefore, the participants should be female.
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yuqing
Phone
86-15942019671
Email
liyuqing1997@gmail.com
Facility Information:
Facility Name
China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yuqing
Phone
86-15942019671
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Hemodynamic Management in Women With SHS
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