Informations générales (source: ClinicalTrials.gov)
Is the Variability of the Perfusion Index Predictive of Post-spinal Hypotension in Parturients Undergoing Scheduled Cesarean Section
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2025
septembre 2025
11 septembre 2025
About one-third of deliveries are performed by cesarean section, and this rate is
increasing. The standard anesthetic technique for this procedure is spinal anesthesia
(SA), which is associated with hypotension in nearly 70% of cases . The mechanism is a
sympatholysis leading to a drop in systemic vascular resistance and cardiac output, which
can be aggravated by relative hypovolemia. This hypotension is responsible for maternal
dizziness, nausea, and vomiting, as well as fetal acidosis, and in extreme cases, fetal
circulatory insufficiency.
Currently, it is recommended to prevent post-spinal hypotension through a strategy
combining co-loading with fluids and the administration of vasopressors in all patients.
However, this non-individualized strategy is not always effective in preventing
hypotension and may even be harmful to the mother in cases of excessive fluid
administration.
Current guidelines for perioperative fluid management in elective surgery advocate for an
individualized approach based on preoperative assessment of preload dependence through
cardiac output monitoring. Correcting this relative hypovolemia helps maintain an
appropriate blood pressure for the patient's needs.
In parturients, we have shown that evaluating preload dependence by measuring the
variation in the time-velocity integral under the aorta (ΔTVI) using cardiac ultrasound
before and after a passive leg raising test (PLR) can predict post-spinal hypotension
with good sensitivity and specificity. We obtained comparable results using monitoring of
the variation in stroke volume by the Clearsight™ system (Edwards Lifesciences, Irvine,
California, US), before and after PLR .
However, these technologies have limitations: availability of equipment, cost, operator
expertise, and patient echogenicity in the case of ultrasound. Using a non-invasive,
simple, and accessible method for monitoring preload dependence that can be used by an
untrained operator would help easily identify patients at higher risk for post-spinal
hypotension, enabling individualized management.
The main objective of our study is to evaluate the ability of ΔIPELJP to predict
post-rachianesthesia hypotension in parturients scheduled for a cesarean section.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Department of Anesthesia and Intensive Care, Perioperative Medicine, Hôpital Nord, - 13000 - Marseille - Marseilles - France | Zieleskiewicz Laurent, MD-PhD | Contact (sur clinicalTrials) | |||
| Hôpital Nord - 13000 - Marseille - France | Laurent MD_PhD ZIELESKIEWICz | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Parturient women
- With a term of more than 34 weeks' amenorrhea (SA)
- Requiring a scheduled caesarean section under spinal anaesthesia at the maternity
ward of the Hôpital Nord de Marseille (AP-HM).
- Patients affiliated to a Social Security System
- Parturient women
- With a term of more than 34 weeks' amenorrhea (SA)
- Requiring a scheduled caesarean section under spinal anaesthesia at the maternity
ward of the Hôpital Nord de Marseille (AP-HM).
- Patients affiliated to a Social Security System
- Urgent caesarean section
- Contraindication to perimedullary anesthesia
- Clinical features likely to distort the plethysmographic signal: scleroderma,
Raynaud's syndrome, nail pathology, etc.
- Presence of anti-hypertensive treatment
- Cardiac arrhythmia
- Anesthetist not trained in transthoracic cardiac echography
- Refusal to participate in the study
- Guardianship or curatorship, safeguard of justice
- Instable Perfusion Index Signal