NCT04519996

Pre-operative Ultrasonographic Evaluation of the Internal Jugular Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index to Predict Post Spinal Hypotension in Pregnant Women Undergoing Caesarean Section

Status unknown NA Last updated 27 October 2020

What this trial tests

NA trial testing US Internal Jugular Vein Collapsibility Index measurment in Cesarean Section in 55 participants. Status unknown.

Timeline

30 October 2020

Primary endpoint
1 November 2020

1 December 2020

Quick facts

Lead sponsor	Tanta University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	55
Start date	30 October 2020
Primary completion	1 November 2020
Estimated completion	1 December 2020

Drugs / interventions tested

• US Internal Jugular Vein Collapsibility Index measurment
• US Inferior Vena Cava Collapsibility Index measurment

Conditions studied

• Cesarean Section — all drugs for Cesarean Section →

Sponsor

Tanta University

Who can join

Adults 20 to 40, female only, with Cesarean Section. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Postspinal hypotension (PSH) is common in obstetric anesthesia practice, with an incidence of up to 71 %. PSH can occur precipitously and, if severe, can result in both maternal and fetal/neonatal adverse events. Pregnant women with predelivery hypovolemia are at risk of cardiovascular collapse and the sympathetic blockade may severely decrease venous return. Hence, prevention of PSH is an essential element in obstetric anesthesia and fasting for aspiration prophylaxis may further add up to the hypovolemia for the patients not on maintenance fluids.

Hemodynamic monitoring in obstetric patients has evolved during the last decade, with the development of minimally invasive and noninvasive continuous cardiac output (CO) monitors. Ultrasound (USG) is a method for noninvasive hemodynamic optimization in the ICU and ED, and it may be more helpful than other noninvasive methods. Transabdominal USG measurements of inferior vena cava (IVC) are noninvasive and thus are not associated with complications. USG of the IVC diameter is a useful and easy method for assessing a patient's volume status by calculating the IVC collapsibility index (IVCCI).

Recently, the usefulness of point-of-care ultrasonographic examination, performed by anesthesiologists in real time, for perioperative management has been reported . Ultrasonographic studies have established the utility of measuring the inferior vena cava (IVC) or internal jugular Vein (IJV) for evaluating intravascular volume status .

In particular, IVC diameter and collapsibility, obtained from ultrasonographic measurement, have been demonstrated to be predictors of hypotension after anesthetic administration.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pre-operative Ultrasonographic Evaluation of the Internal Jugular Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index to Predict Post Spinal Hypotension in Pregnant Women Undergoing Caesarean Section.
   Elbadry AA, El Dabe A, Abu Sabaa MA. · · 2022 · cited 14× · PMID 35433379 · DOI 10.5812/aapm.121648