Hemodynamic Management in Women With SHS
Hemodynamic Management Target on Continuous Monitoring in Cesarean Delivery-A Randomized Controlled Trial in Patients With Supine Hypotensive Syndrome
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2022
CompletedStudy Start
First participant enrolled
April 17, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 7, 2023
March 1, 2023
1.1 years
April 10, 2022
March 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Umbilical arterial blood gas PH
The value is tested immediately after the blood sample is achieved after the infant is born.
30minutes
Secondary Outcomes (4)
Discomfort Score
1day
total vasopressor dosage
30 minutes
Umbilical blood gas lactate
30minutes
Time span
2 hours
Study Arms (2)
Blank Group
NO INTERVENTIONIn this group, the anesthesia management is conducted according to the anesthetists' experience, based on the regular monitor.
LiDCOrapid Group
EXPERIMENTALIn this group, the anesthesia management is conducted based on both the regular monitor and the hemodynamic figures on the LiDCOrapid.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients undergoing emergency CD, CD under general anesthesia or patients' refusal to participate, or multiple fetations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University
Shenyang, Liaoning, 110000, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Undergraduate doctor
Study Record Dates
First Submitted
April 10, 2022
First Posted
April 22, 2022
Study Start
April 17, 2022
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
March 7, 2023
Record last verified: 2023-03