An observational study in Hypotension, sponsored by University of Catania. Completed at 1 site in Italy. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-11-27.
Sponsored by University of Catania · Observational
Spinal anesthesia has long been considered the first choice technique in caesarean section, but although it is a reliable and safe procedure, it is in some cases associated with undesirable effects. Maternal hypotension after sub-arachnoid anesthesia is a reduction in systolic blood pressure below 100 mmHg or a decrease of 20% compared to baseline values. According to some authors, maternal hypotension occurs up to 80% in women undergoing caesarean section after spinal anesthesia. In order to reduce the incidence of maternal hypotension, some measures can be taken:
The main objective of the study is to investigate, through the use of a continuous non-invasive hemodynamic monitoring system (Clearsight® - Edwards Lifesciences), the incidence of hypotension in pregnant women at risk undergoing spinal anesthesia due to elective cesarean section.
In this prospective observational not-for profit study, 128 patients will be enrolled to measure the incidence of hypotension during spinal anesthesia for elective cesarean section. On the occasion of the preoperative visit, all patients to be subjected to elective cesarean section will be subjected to the Postural Change Test (PCT), a predictive test for maternal hypotension during spinal anesthesia that evaluate changes in heart rate of pregnant women following postural changes. Specifically, after monitoring the heart rate in the supine position, the patient is asked to change decubitus (from supine to left lateral and then back to supine). The test is positive if the patient's heart rate changes more than 10% from baseline.
Once arrived in the obstetric emergency department, parturients with positive Postural Change Test will be subjected to cannulation of a peripheral vein through a 18-20 Gauge needle cannula and the Clearsight hemodynamic monitoring system will be placed on a finger. The investigators will then proceed to the detection of the following parameters:
Once the spinal block has been performed, the patient will be immediately placed in a supine position. The investigators will then continue monitoring the parameters listed above using Clearsight® (SV, SVI, MAP, CI) at 2-minute intervals in the phases following spinal anesthesia:
Any hemodynamic changes (MAP \<60 mmHg or CI \<2.5), under volemic optimization conditions, will be treated by administration of vasoconstrictors (Etilefrine, intravenous bolus of 1-3 mg).
At the afterbirth, the investigators will proceed to the infusion of liquids and uterotonic according regimens in use at the unit of Anesthesia and Intensive Care of the Universitary Hospital "G. Rodolico" of Catania.
Given the descriptive nature of the study, a formal calculation of the sample size was not made. As secondary end-points, the Stroke Volume variation following spinal anesthesia, the amount of fluids administered, the vasoconstrictor doses used, diuresis, the Apgar index and the fetal pH will be measured. The number of hypotension episodes not detected by the traditional blood pressure monitoring system but detected by the Clearsight system will also be recorded. For the qualitative variables, the absolute frequencies and the percentage frequencies will be calculated. For the quantitative variables, if with normal distribution, mean and standard deviation will be calculated; if with not normal distribution, median and interquartile range will be calculated.
The normality of the distribution will be evaluated through the Kolmogorov-Smirnoff test.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 148 is above the median of 84 across 294 observational studies indexed under Hypotension.
Browse Hypotension studies →University of Catania is the lead sponsor of 68 studies on the registry; 14 are open to participants now.
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148 pregnant women, at risk of developing hypotension, undergoing spinal anesthesia for elective Caesarean section at the Universitary Hospital "G. Rodolico" of Catania
Exclusion Criteria:
Incidence of hypotension assessed through the use of the non-invasive hemodynamic monitoring system ClearSight
Time frame: Intraoperatively
Modifications of Stroke Volume (SV) from basal
Time frame: 2 minutes after spinal anesthesia
Modifications of Stroke Volume (SV) from basal
Time frame: 4 minutes after spinal anesthesia
Modifications of Stroke Volume (SV) from basal
Time frame: 6 minutes after spinal anesthesia
Modifications of Stroke Volume (SV) from basal
Time frame: 8 minutes after spinal anesthesia
Modifications of Stroke Volume (SV) from basal
Time frame: 2 minutes after cutaneous incision
Modifications of Stroke Volume (SV) from basal
Time frame: 2 minutes after uterine incision
Modifications of Stroke Volume (SV) from basal
Time frame: 2 minutes after extraction
Modifications of Stroke Volume Index (SVI) from basal
Time frame: 2 minutes after spinal anesthesia
Modifications of Stroke Volume Index (SVI) from basal
Time frame: 4 minutes after spinal anesthesia
Modifications of Stroke Volume Index (SVI) from basal
Time frame: 6 minutes after spinal anesthesia
Modifications of Stroke Volume Index (SVI) from basal
Time frame: 8 minutes after spinal anesthesia
Modifications of Stroke Volume Index (SVI) from basal
Time frame: 2 minutes after cutaneous incision
Modifications of Stroke Volume Index (SVI) from basal
Time frame: 2 minutes after uterine incision
Modifications of Stroke Volume Index (SVI) from basal
Time frame: 2 minutes after extraction
Modifications of Cardiac Index (CI) from basal
Time frame: 2 minutes after spinal anesthesia
Modifications of Cardiac Index (CI) from basal
Time frame: 4 minutes after spinal anesthesia
Modifications of Cardiac Index (CI) from basal
Time frame: 6 minutes after spinal anesthesia
Modifications of Cardiac Index (CI) from basal
Time frame: 8 minutes after spinal anesthesia
Modifications of Cardiac Index (CI) from basal
Time frame: 2 minutes after cutaneous incision
Modifications of Cardiac Index (CI) from basal
Time frame: 2 minutes after uterine incision
Modifications of Cardiac Index (CI) from basal
Time frame: 2 minutes after extraction
Need for inotropes and / or vasopressor during surgery
Doses of inotropes and / or vasopressor administered during surgery
Time frame: Intraoperatively
Need for fluids administration during surgery
Volume of fluids administered during surgery for the eventual treatment of hypotension
Time frame: Intraoperatively
Volume of urine excreted during surgery
Time frame: Intraoperatively
Evaluation of fetal health through Apgar score
The Apgar score is determined by evaluating the newborn baby on five simple criteria (skin color, pulse rate, reflex irritability grimace, activity and respiratory effort) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The test is done at 1 and 5 minutes after birth and may be repeated later if the score is and remains low. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
Time frame: At 1 and at 5 minute after birth
Number of hypotension episodes not detected by the traditional pressure cuff but detected by the Clearsight system
Time frame: Intraoperatively
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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University of Catania