The Effect of Left Uterine Displacement on Parturient Cardiovascular System

Study Overview
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Brief Summary
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The aim of the study is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after spinal anesthesia

Detailed Description
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At operating room, patients will be monitored using non invasive blood, ECG, pulse oximeter and electrical cardiometry. Baseline readings will be taken in supine position then repeated after putting the patient in left lateral position with angle 15 then 30 degrees. Then two IV lines will be inserted and 500cc crystalloid will be administered. Subarachnoid block will be performed in sitting position under complete aseptic conditions using 25 g spinal needle. Subarachnoid block will be achieved by injecting 10 mg hyperbaric bupivacaine plus 25 ug fentanyl. The block will be considered successful if adequate block reached T4 dermatome. After successful block the hemodynamic variables will be recorded in the same positions as before (0,15, 30 degrees left uterine tilt). A minimum number of 61 patients was calculated to have a study power of 80% and alpha error of 0.05. SPSS Chicago 18 software will be used for data analysis. Categorical data will be presented as frequencies, continuous variables will presented as mean ± standard deviation and will be analyzed using on way analysis of variance (ANOVA) with post-hoc pairwise comparisons using bonferroni test. A P value of 0.05 will be considered statistically significant.

Official Title
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Hemodynamics Effects of Left Lateral Tilt on the Full Term Pregnant Females

Conditions
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Cardiac Output

Intervention / Treatment
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* Procedure: electric cardiometry
* Procedure: IV line insertion
* Procedure: spinal anesthesia ( subarachnoid block )
* Procedure: electric cardiometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: full term, singleton, American society of anesthesiologists (ASA) I and II pregnant women scheduled for cs Exclusion Criteria: BMI > 35 Kg/m2 polyhydramnios history of impaired cardiac contractility valvular heart disease cardiac arrhythmias hypertensive pregnancy disorders fetal abnormalities

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: electric cardiometry|The following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance. these parameters are measured on arrival to operating room before subarachnoid block in three different angles of lateral uterine tilt ( 0, 15 and 30 degrees )|
|Procedure: IV line insertion|two Iv lines are inserted and 500cc crystalloid is administered to parturient .|
|Procedure: spinal anesthesia ( subarachnoid block )|Subarachnoid block (SAB) was performed in sitting position under complete asepsis using 25 g spinal needle. SAB was achieved by intrathecal injection of 10 mg hyperbaric bupivacaine plus 25ug fentanyl. Success of SAB was tested within five minutes after drug injection. SAB was considered successful if adequate block reached T4 dermatome.|
|Procedure: electric cardiometry|after SAB the following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance at three different angles of left uterine lilt (0,15,30 degrees)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in cardiac output (L/min) before anesthesia | measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany). | baseline : 5min after putting the patient in supine position then 1min after left uterine tilt at 15 and 30 degrees | 
| change in cardiac output (L/min) after spinal anesthesia | measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany). | baseline after assessing adequate block reaching T4 dermatome then 1 min after left uterine tilt at 15 and 30 degrees | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in systemic vascular resistance (dyn.s/cm5) |  | baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block | 
| change in mean arterial blood pressure (mmHg) | measured by oscillometry in mmHg | baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiometry, uterine displacement