Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography

NCT02471924 | Completed

• 1 other identifier: 2015-13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by a hypotension in 40% to 90% despite preventing tools. Hypotension is responsible of foetale and maternal suffering. It would be interesting to have a tool that could detect patient who are at risk to have hypotension.This study consist in measuring variations of under aortic velocity peak (ΔITVAo) which estimate the modification of the cardiac output by Trans thoraciq echography.

Conditions

Pregnancy

Keywords

Pregnant women

Outcome Measures

Primary Outcomes (1)

• Establish a diagnosis power of the ΔITVAo measured with cardiac ultrasonography after passiv leg rising to predict hypotension after spinal anesthesia for elective caesarean.

  ITVAo corresponds to the variation of complete time speed under aortic between the measure position half seat and the measure of the ITVAo during the test of rise of passive leg. ITVAo is a reflection of the variation of the volume of systolic ejection. The variation of the volume of systolic ejection led during the test of rise of passive leg, measured in cardiac ultrasound , predicts the answer to the vascular filling at patients of resuscitation The definition retained for the low blood pressure is a fall of 20 % of the mean arterial blood pressure of base in the first 15 minutes which follow the spinal anesthesia. The basic value of the mean arterial blood pressure is defined as the average of 3 mean arterial blood pressure measures in 3 minutes apart in dorsal decubitus before the practice of the spinal anesthesia

  1 year

Secondary Outcomes (3)

• Estimate if ΔITVAo is linked to an increase in vasoactiv drugs

  1 year

• Estimate if ΔITVAo is linked to fœtal suffering (low acido basic statues in blood section and low APGAR score)

  1 year

• Estimate if other echographic measures are linked to hypotension after spinal anesthesia

  1 year

Study Arms (1)

Trans thoraciq cardiac ultrasonography

OTHER

Trans thoraciq cardiac ultrasonography wil be perforfomed for pregnant women having a spinal or spinal-epidural anesthesia for elective caesarean section. All patients are more 18 years old and more 37 weeks pregnancy

Other: Trans thoraciq cardiac ultrasonography

Interventions

Trans thoraciq cardiac ultrasonography OTHER

Establish a diagnosis power of the ΔITVAo ( aortic velocity peak )measured with cardiac Trans thoraciq ultrasonography after passiv leg rising to predict hypotension after spinal anesthesia for elective caesarean. Every patients participate for 30 minutes (time to perform the echography). Outside echographic evaluation, medical taking of participating patients will be exactly the same than what is done for all elective caesarean section.

Trans thoraciq cardiac ultrasonography

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Included patient are all women having a spinal or spinal-epidural anesthesia for elective caesarean section. All patients are more 18 years old and more 37 weeks pregnancy.
• Physical statut score (ASA):1 or 2

You may not qualify if:

• Woman presenting a contraindication to the spinal epidural anesthesia : constitutional or acquired disorder of the haemostasis
• allergy in the local anesthetics,
• infectious context (hypertherm \> 38.5 ° C)
• · cardiac, right or left Insufficiency
• eclamptic toxemia

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• Zieleskiewicz L, Noel A, Duclos G, Haddam M, Delmas A, Bechis C, Loundou A, Blanc J, Mignon A, Bouvet L, Einav S, Bourgoin A, Leone M. Can point-of-care ultrasound predict spinal hypotension during caesarean section? A prospective observational study. Anaesthesia. 2018 Jan;73(1):15-22. doi: 10.1111/anae.14063. Epub 2017 Oct 7.

  PMID: 28986931 DERIVED

Study Officials

• Carole BECHIS, MD

  Assistance Publique Hopitaux De Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 15, 2015
• Study Start: June 17, 2015
• Primary Completion: February 20, 2017
• Study Completion: October 10, 2017
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

FR (1)