The Effect of Left Uterine Displacement on Parturient Cardiovascular System

Cardiac Output Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828176
• Other study ID #: cardiometry
• Status: Completed
• Phase: N/A
• First received: June 21, 2016
• Last updated: July 9, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Output

Intervention

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 )
• IV line insertion
two Iv lines are inserted and 500cc crystalloid is administered to parturient .
• 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.
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

Cluver C, Novikova N, Hofmeyr GJ, Hall DR. Maternal position during caesarean section for preventing maternal and neonatal complications. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD007623. doi: 10.1002/14651858.CD007623.pub3. Review. — View Citation

Higuchi H, Takagi S, Zhang K, Furui I, Ozaki M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Feb;122(2):286-93. doi: 10.1097/ALN.0000000000000553. — View Citation

HOWARD BK, GOODSON JH, MENGERT WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953 Apr;1(4):371-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No