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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Spinal Anesthesia; Cesarean

Treatments: Other: Clinical hemodynamic and echocardiographic evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT05133271

2021-A01099-32 (Other Identifier)

APHP210937

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Scheduled cesarean section

Experimental group

Description:

Patient with scheduled cesarean section under spinal anesthesia.

Treatment:

Other: Clinical hemodynamic and echocardiographic evaluation