Clinical trial NCT06885593: Femoral Vein Collapsibility Index and Post-Spinal Hypotension in Pregnant Women: Impact of Position
Official title: "Can Femoral Vena Cava Collapsibility Index Predict Post-spinal Hypotension in Pregnant Women in Left Lateral Tilt Position?"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Induced Hypotension in Cesarean Delivery
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All ultrasonography (USG) procedures will be performed by the same anesthesiologist using a Ultrasound device before the start of spinal anesthesia (SA) and after baseline blood pressure and heart rate have been measured. Patients will be placed in supine and left lateral tilt (LLT) positions. After at least 3 minutes in each position, ultrasound of the inferior vena cava (IVC) and femoral vein (FV) will be performed. The oblique probe will be placed below the xiphoid. Anteroposterior diameters and peak velocities of the IVC will be measured 2-3 cm below the IVC-right atrium For standardization purposes, measurements of the right femoral vein will be used in the study. The FV will be visualized with B-mode ultrasound 2-5 cm below the level of the inguinal ligament where the femoral artery is best palpated, without applying any pressure that may affect the FV diameter.
Primary purpose: PREVENTION

Brief summary: This study aims to improve the safety of spinal anesthesia for pregnant patients undergoing elective cesarean delivery. Specifically, the investigators are investigating whether ultrasound measurements of a vein in the groin (the right common femoral vein, or RCFV) can help predict the risk of low blood pressure (hypotension) after spinal anesthesia. The main question it aims to answer is:

Can femoral vena cava collapsibility index predict post-spinal hypotension in pregnant women in left lateral tilt position?

Before receiving spinal anesthesia, participants will undergo a brief and painless ultrasound examination of the RCFV in the groin area while lying in a specific position."

Detailed description: Post-spinal hypotension (PSH) is defined as a systolic arterial blood pressure (SBP) decrease of more than 20% from baseline or an SBP drop below 100 mmHg. This reduction in blood pressure may compromise uteroplacental perfusion, leading to fetal hypoxia and acidosis. PSH is the most common complication in obstetric anesthesia, with an incidence of up to 95% in healthy women. Despite extensive research, the most effective strategy to maintain hemodynamic stability remains under investigation. Various methods, including crystalloid and colloid fluid loading, leg wrapping, head-down tilt, and vasopressor use, have been explored for both treatment and prevention.

The sympatholytic effect of spinal anesthesia induces vasodilation, exacerbating maternal hypotension due to the gravid uterus compressing the inferior vena cava (IVC). This compression reduces venous return and subsequently decreases the IVC diameter.

Current recommendations for term pregnant women undergoing cesarean delivery advocate for a left lateral tilt position to prevent aortocaval compression (ACC), maternal hypotension, and fetal compromise . In the supine position, the IVC is nearly completely obstructed at term up to its bifurcation. However, most women experience only minimal hemodynamic effects due to compensatory mechanisms such as venoconstriction in the lower extremities and collateral circulation via the paraspinal and azygos veins. Clinically significant hemodynamic compromise, known as supine hypotensive syndrome, occurs in approximately 8-10% of term pregnancies, likely due to insufficient compensatory responses .

The right common femoral vein (RCFV), a continuation of the right external iliac vein, is a tributary of the IVC. Because the RCFV is superficially located, it can be easily visualized using a high-frequency ultrasound probe. Importantly, the RCFV is situated distal to the site of aortocaval compression, making it a potential surrogate marker for hemodynamic changes.

Study Hypothesis This study hypothesizes that the peak velocity and collapsibility index of the RCFV in the inguinal region, measured in the left lateral 15-degree tilt position, reflect the degree of aortocaval compression. These parameters may help identify pregnant women at high risk of post-spinal hypotension during elective cesarean delivery.

Eligibility criteria: Inclusion Criteria:

* ASA 2
* Uncomplicated pregnancy
* Height between 150 cm-180 cm
* Signed the informed consent form
* 8 hours of fasting before the operation
* Patients who refuse normal delivery

Exclusion Criteria:

* Obstetric comorbidities affecting caval compression of the aorta
* Transverse development
* Fetal macrosomia
* Uterine anomaly
* Polyhydramnion
* Oligohydroamnion
* Membrane ruptures
* Intrauterine growth retardation
* Mothers with hyperactive lung disease
* Those with autonomic neuropathy
* Kidney failure
* Smokers
* Severe scoliosis or kyphosis
* Multiple pregnancy (twins, triplets,...)
* Those who do not reach T6 sensory block level after 10 minutes
* Those undergoing general anesthesia or IV analgesics for any reason

Primary outcomes:
measure: Number of Participants with Post-Spinal Hypotension
timeFrame: 40 minute
Secondary outcomes:
measure: Number of Participants with time of onset of maternal hypotension, symptomatic hypotension, incidence of bradycardia, cumulative ephedrine requirements, patient satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf Univeristesi Dragos Hastanesi Yalı, Kennedy Cd. No:16.
Study officials:
References:
citation: Yao SF, Zhao YH, Zheng J, Qian JY, Zhang C, Xu Z, Xu T. The transverse diameter of right common femoral vein by ultrasound in the supine position for predicting post-spinal hypotension during cesarean delivery. BMC Anesthesiol. 2021 Jan 20;21(1):22. doi: 10.1186/s12871-021-01242-8.
citation: Lal J, Jain M, Rahul, Singh AK, Bansal T, Vashisth S. Efficacy of inferior vena cava collapsibility index and caval aorta index in predicting the incidence of hypotension after spinal anaesthesia- A prospective, blinded, observational study. Indian J Anaesth. 2023 Jun;67(6):523-529. doi: 10.4103/ija.ija_890_22. Epub 2023 Jun 14.