Hemodynamic Management in Women With SHS

Study Overview
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Brief Summary
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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.

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

Conditions
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Supine Hypotensive Syndrome

Intervention / Treatment
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* Procedure: LiDCOrapid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Blank Group<br>In this group, the anesthesia management is conducted according to the anesthetists' experience, based on the regular monitor. | |
| Experimental: LiDCOrapid Group<br>In this group, the anesthesia management is conducted based on both the regular monitor and the hemodynamic figures on the LiDCOrapid. | Procedure: LiDCOrapid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umbilical arterial blood gas PH | 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 | 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 | total vasopressor given during the time span between the operation began to the baby was delivered | 30 minutes | 
| Umbilical blood gas lactate | The value is tested immediately after the blood sample is achieved after the infant is born. | 30minutes | 
| Time span | the period between the operation began to the baby was delivered | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supine hypotensive syndrome, cesarean delivery, spinal anesthesia, CSEA