Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this randomized controlled trial is to compare for non inferiority for fetal wellbeing Hypotension Prediction Index - Guided Therapy and Continuous Norepinephrine Infusion in in the Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery.
The main question it aims to answer are:
• are fetal arterial base excess comparable with the two treatments?
Participants will undergo continuous noninvasive hemodynamic monitoring with advanced Hypotension Prediction Index Researchers will compare with patients receiving continuous norepinephrine infusion and standard blood pressure monitoring with arm cuff.
In the Hypotension Prediction Index group, patients will be monitored continuously with a noninvasive hemodynamic device. The Hypotension Prediction Index is a number based on al algorithm that predicts impeding hypotension if it is greater than 85. In the treatment group, patients will be treated with norepinephrine boluses if the Hypotension Prediction Index is >85. In the control group patients will be treated with preventive continuous infusion of norepinephrine and blood pressure will be measured noninvasively every minute. Data about blood pressure and the vasopressive treatment will start concomitantly to the administration of spinal anesthesia and will stop after delivery. blood gas samples will be then collected from the placental umbilical artery to compare fetal arterial base excess as primary outcome for non-inferiority.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypotension Prediction Index | Experimental | Patients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine |
|
| Non Invasive Blood Pressure | Active Comparator | Spinal-induced hypotension will be prevented by continuous preventive norepinephrine infusion and blood pressure will be monitored by non invasive arm cuff every minute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypotension Prediction Index | Device | in addition to standard monitoring, will have hemodynamic monitoring using HemoSphere (Edwards Lifesciences, Irvine, CA; internal memory 60 gigabyte, 10 gigabyte used for operating system) with ClearSight non-invasive hemodynamic monitoring and with the Hypotension Prediction Index software enabled. They will not receive preventive vasopressors but only norepinephrine boluses if Hypotension Prediction Index >85 |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Base excess | withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis | at birth |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotensive episodes | (sistolic blood pressure <80% of baseline values for <1 minute) | from spinal anesthesia until delivery |
| Total vasopressor dose | total dose of micrograms administered during operation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
pregnant women at term
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara Sonnino, MD | Contact | +390630153105 | chiara.sonnino@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Gaetano A Draisci, Prof | IRCCS fondazione policlinico universitario A. Gemelli | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Norepinephrine | Drug | Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85 |
|
|
| from spinal anesthesia until delivery |
| Hypertensive episodes | systolic blood pressure >140 mmHg and/or diastolic blood pressure >100 mmHg | from spinal anesthesia until delivery |
| Fetal arterial pH | value of fetal ph at the analisys from umbilical artery withdrown at birth | at birth |
| Apgar score | Apgar is a quick test performed on a baby at 1 and 5 minutes after birth, examines the baby's breathing effort, heart rate, muscle tone, reflexes, skin color. Each category is scored with 0, 1, or 2, depending on the observed condition. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. | at 5 minutes from birth |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided