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Prediction of Maternal Arterial Hypotension After Spinal Anesthesia by Passive Leg Raise Test. (EDLIDL)

Primary Purpose

Cesarean, Spinal Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical hemodynamic and echocardiographic evaluation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cesarean focused on measuring Passive leg raise test (PLR), Cesarean section, Spinal anesthesia, Maternal arterial hypotension, Phenylephrine requirements, Norepinephrine requirements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult women admitted to Necker Enfants Malades hospital for scheduled cesarean section under spinal anesthesia
  • Written informed consent

Exclusion Criteria:

  • No health insurance
  • Urgent cesarean
  • Failure of spinal anesthesia
  • Free and informed consent impossible to obtain (especially due to a language barrier)
  • Severe cardiovascular or neurovascular comorbidities
  • Contraindication to the PLR (intracranial hypertension, fractures of the pelvis and / or lower limbs, ...)
  • Background of preeclampsia or eclampsia
  • Severe fetal pathology

Sites / Locations

  • Hôpital Necker-Enfants MaladesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Scheduled cesarean section

Arm Description

Patient with scheduled cesarean section under spinal anesthesia.

Outcomes

Primary Outcome Measures

Maternal arterial hypotension
Maternal arterial hypotension following spinal anesthesia. Maternal hypotension is defined as a drop in systolic blood pressure (SBP)> 20% of baseline.
Positivity of passive leg raise test
A positive passive leg raise test is defined as an increase in the Subaortic Flow Velocity Time Integral of 10% or more. The increase in cardiac output is measured by a cardiac ultrasound.
Positive passive leg raise test performance
Performance of a positive passive leg raise test in predicting the onset of maternal arterial hypotension after spinal anesthesia. Significant performance will be defined by sensitivity and specificity > 90%.

Secondary Outcome Measures

Total dose of norepinephrine
Total dose of norepinephrine received during the procedure from the beginning of the spinal anesthesia injection up to umbilical cord clamping measured in micrograms.
Onset of severe arterial hypotension
Onset of severe arterial hypotension defined as a drop in systolic blood pressure greater than 30% of baseline.
Onset of nausea and vomiting
Onset of nausea and vomiting from the spinal anesthesia injection up to the end of the c-section.
Occurrence of disturbances of consciousness
Occurrence of consciousness alteration assessed by the Glasgow Coma Scale (from Teasdale G & Jennett B. Lancet 1974). Three aspects of behavior are measured independently: motor response, verbal response and eye opening. Each component has a number of grades starting with the most severe. The best ocular response has 4 grades; the best verbal response has 5 grades; the best motor response has 6 grades. Rating: the score of each component as well as the sum of the components are considered. The total score is out of 15 points; lower scores indicating more severe impairment. The lowest possible score is 3, indicating deep coma or death, and the highest possible score is 15, indicating a fully awake individual.
Occurrence of sedation and agitation
Occurrence of sedation and agitation during the c-section assessed by the Richmond Agitation-Sedation scale (RASS). This score is based on the observation of the patient It has 10 stages ranging from +4 (combative patient) to -5 (patient who cannot be woken up).
Assessment of fetal well-being
Evaluation of fetal well-being by fetal heartbeat, by the Apgar score at 1, 3 and 5 minutes of life, and study of the pH in the umbilical cord, a pH value <7.2 defines fetal distress.
Quality of ultrasound images
Assessment of obtaining views (parasternal long-axis view, parasternal short-axis view, apical 4-chamber view, subcostal). Interpretability of the measurements obtained.
Relative or absolute hypovolemia
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy. To note the parameters suggestive of relative or absolute hypovolaemia: inferior vena cava diameter < 8 mm; "kissing sign" of the left ventricle, defined as à end-systolic collapse of the left ventricle; E/A ratio < 1.
Right ventricle systolic or diastolic dysfunction
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy. Right ventricle systolic function: measurement of the TAPSE (tricuspid annular plane systolic excursion; presence of a paradoxical septal motion (yes/no). Right ventricle diastolic function: presence of right ventricle dilation defined as end-diastolic right ventricle area (EDRVA) / end-diastolic left ventricle area (EDLVA) > 0.6; "severe" dilatation is defined as a ratio > 1.
Left ventricle systolic and diastolic dysfunction
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy. Left ventricle systolic function: left ventricle ejection fraction (LVEF) - apical-4-chamber view - defined as LVEF = (EDLVA-ESLVA)/EDLVA Left ventricle shortening fraction (LVSF) - parasternal short-axis view - defined as LVSF = (EDLVA-ESLVA)/EDLVA MAPSE (mitral annular plane systolic excursion Left ventricle diastolic function: Mitral flow profile: E wave / A wave ratio Left atrium area (cm²)
Pericardial effusion
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy. Measurement of the size (in mm) of the pericardial effusion (left and right ventricles lateral walls).
Maternal comfort during the passive leg raising
Assessment of the maternal comfort during the passive leg raising test with a numerical scale (from 0: maximal discomfort to 10: maximal comfort).
Heart rate
Association of increased up heart rate and total dose of neosynephrine at the end of the c-section.

Full Information

First Posted
November 15, 2021
Last Updated
March 15, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05133271
Brief Title
Prediction of Maternal Arterial Hypotension After Spinal Anesthesia by Passive Leg Raise Test.
Acronym
EDLIDL
Official Title
Assessment of the Value of Passive Leg Raising (PLR) in Predicting the Onset of Maternal Arterial Hypotension and Norepinephrine Requirements After Spinal Anesthesia for Scheduled Cesarean Section.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension. The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.
Detailed Description
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension. The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity. Patients will have a clinical hemodynamic and echocardiographic evaluation, before performing the spinal anesthesia, before and after the passive leg raise test. Then, the patients will benefit from a clinical hemodynamic evaluation during the preparation of the parturient in the operating room and finally after the completion of the spinal anesthesia and until the clamping of the umbilical cord.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean, Spinal Anesthesia
Keywords
Passive leg raise test (PLR), Cesarean section, Spinal anesthesia, Maternal arterial hypotension, Phenylephrine requirements, Norepinephrine requirements

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scheduled cesarean section
Arm Type
Experimental
Arm Description
Patient with scheduled cesarean section under spinal anesthesia.
Intervention Type
Other
Intervention Name(s)
Clinical hemodynamic and echocardiographic evaluation
Intervention Description
Clinical hemodynamic and echocardiographic evaluation in two stages T1 and T2, before performing the spinal anesthesia, carried out by a doctor different from the doctor in charge of the parturient in the operating room to ensure the blind hemodynamic results before the spinal anesthesia, in particular those of the passive leg raise test (PLR) : T1: clinico-echographic evaluation in dorsal decubitus position (45 °) with cushion under the right buttock. T2: clinico-ultrasound evaluation after performing the PLR. Then, clinical hemodynamic evaluation during two periods T3 and T4: T3: conditioning time of the parturient in the operating room during which clinical hemodynamic monitoring is set up and the basic values of arterial pressures (systolic, diastolic and mean) and heart rate are defined. T4: period after performing spinal anesthesia until clamping of the umbilical cord.
Primary Outcome Measure Information:
Title
Maternal arterial hypotension
Description
Maternal arterial hypotension following spinal anesthesia. Maternal hypotension is defined as a drop in systolic blood pressure (SBP)> 20% of baseline.
Time Frame
Day 0
Title
Positivity of passive leg raise test
Description
A positive passive leg raise test is defined as an increase in the Subaortic Flow Velocity Time Integral of 10% or more. The increase in cardiac output is measured by a cardiac ultrasound.
Time Frame
Day 0
Title
Positive passive leg raise test performance
Description
Performance of a positive passive leg raise test in predicting the onset of maternal arterial hypotension after spinal anesthesia. Significant performance will be defined by sensitivity and specificity > 90%.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Total dose of norepinephrine
Description
Total dose of norepinephrine received during the procedure from the beginning of the spinal anesthesia injection up to umbilical cord clamping measured in micrograms.
Time Frame
Day 0
Title
Onset of severe arterial hypotension
Description
Onset of severe arterial hypotension defined as a drop in systolic blood pressure greater than 30% of baseline.
Time Frame
Day 0
Title
Onset of nausea and vomiting
Description
Onset of nausea and vomiting from the spinal anesthesia injection up to the end of the c-section.
Time Frame
Day 0
Title
Occurrence of disturbances of consciousness
Description
Occurrence of consciousness alteration assessed by the Glasgow Coma Scale (from Teasdale G & Jennett B. Lancet 1974). Three aspects of behavior are measured independently: motor response, verbal response and eye opening. Each component has a number of grades starting with the most severe. The best ocular response has 4 grades; the best verbal response has 5 grades; the best motor response has 6 grades. Rating: the score of each component as well as the sum of the components are considered. The total score is out of 15 points; lower scores indicating more severe impairment. The lowest possible score is 3, indicating deep coma or death, and the highest possible score is 15, indicating a fully awake individual.
Time Frame
Day 0
Title
Occurrence of sedation and agitation
Description
Occurrence of sedation and agitation during the c-section assessed by the Richmond Agitation-Sedation scale (RASS). This score is based on the observation of the patient It has 10 stages ranging from +4 (combative patient) to -5 (patient who cannot be woken up).
Time Frame
Day 0
Title
Assessment of fetal well-being
Description
Evaluation of fetal well-being by fetal heartbeat, by the Apgar score at 1, 3 and 5 minutes of life, and study of the pH in the umbilical cord, a pH value <7.2 defines fetal distress.
Time Frame
Day 0
Title
Quality of ultrasound images
Description
Assessment of obtaining views (parasternal long-axis view, parasternal short-axis view, apical 4-chamber view, subcostal). Interpretability of the measurements obtained.
Time Frame
Day 0
Title
Relative or absolute hypovolemia
Description
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy. To note the parameters suggestive of relative or absolute hypovolaemia: inferior vena cava diameter < 8 mm; "kissing sign" of the left ventricle, defined as à end-systolic collapse of the left ventricle; E/A ratio < 1.
Time Frame
Day 0
Title
Right ventricle systolic or diastolic dysfunction
Description
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy. Right ventricle systolic function: measurement of the TAPSE (tricuspid annular plane systolic excursion; presence of a paradoxical septal motion (yes/no). Right ventricle diastolic function: presence of right ventricle dilation defined as end-diastolic right ventricle area (EDRVA) / end-diastolic left ventricle area (EDLVA) > 0.6; "severe" dilatation is defined as a ratio > 1.
Time Frame
Day 0
Title
Left ventricle systolic and diastolic dysfunction
Description
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy. Left ventricle systolic function: left ventricle ejection fraction (LVEF) - apical-4-chamber view - defined as LVEF = (EDLVA-ESLVA)/EDLVA Left ventricle shortening fraction (LVSF) - parasternal short-axis view - defined as LVSF = (EDLVA-ESLVA)/EDLVA MAPSE (mitral annular plane systolic excursion Left ventricle diastolic function: Mitral flow profile: E wave / A wave ratio Left atrium area (cm²)
Time Frame
Day 0
Title
Pericardial effusion
Description
Describe the echocardiographic parameters reflecting the different physiopathological mechanisms at the origin of arterial hypotension secondary to spinal anesthesia of the parturient at the end of pregnancy. Measurement of the size (in mm) of the pericardial effusion (left and right ventricles lateral walls).
Time Frame
Day 0
Title
Maternal comfort during the passive leg raising
Description
Assessment of the maternal comfort during the passive leg raising test with a numerical scale (from 0: maximal discomfort to 10: maximal comfort).
Time Frame
Day 0
Title
Heart rate
Description
Association of increased up heart rate and total dose of neosynephrine at the end of the c-section.
Time Frame
Day 0

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patient with scheduled cesarean section under spinal anesthesia.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult women admitted to Necker Enfants Malades hospital for scheduled cesarean section under spinal anesthesia Written informed consent Exclusion Criteria: No health insurance Urgent cesarean Failure of spinal anesthesia Free and informed consent impossible to obtain (especially due to a language barrier) Severe cardiovascular or neurovascular comorbidities Contraindication to the PLR (intracranial hypertension, fractures of the pelvis and / or lower limbs, ...) Background of preeclampsia or eclampsia Severe fetal pathology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Repessé, MD
Phone
1 71 39 68 89
Ext
+33
Email
xavier.repesse@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène Morel
Phone
1 71 19 63 46
Ext
+33
Email
helene.morel@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Repessé, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hawa Keita-Meyer, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Repessé, MD
Phone
1 71 39 68 89
Ext
+33
Email
xavier.repesse@aphp.fr
First Name & Middle Initial & Last Name & Degree
Lauranne Ossé, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Prediction of Maternal Arterial Hypotension After Spinal Anesthesia by Passive Leg Raise Test.

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