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

NCT04519996 | Unknown DMC

• 1 other identifier: IJVCI versus IVCCI
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cesarean Section

Keywords

cesarean section; hypotension

Outcome Measures

Primary Outcomes (2)

• pre-operative inferior vena cava collapsibility index (IVCCI)

  for predicting post-spinal anaesthesia hypotension (PSAH). The maximum (IVCD) and minimum (IVCD) internal anteroposterior (AP) diameters of the IVC at the end of expiration and inspiration respectively over the same respiratory cycle will be measured. The IVCCI is derived from the equation, IVCCI= (IVCD max -IVCD min)/IVCD max × 100

  pre-operative

• pre-operative internal jugular vein collapsibility index (IJVCI)

  for predicting post-spinal anaesthesia hypotension (PSAH), The maximum, minimum antero-pestorior diameters, and cross-sectional area will be estimated and, from this, corresponding collapsibility index will be derived (Maximum diameter or cross-sectional area (CSA)-minimum diameter or CSA/maximum diameter or CSA) ×100%.

  pre-operative

Study Arms (2)

US Internal Jugular Vein Collapsibility Index

EXPERIMENTAL

The US transducer will be placed on the right side of the neck in the transverse plane over RIJV 2 cm above the sternoclavicular joint. The IJV will be identified by the color flow Doppler and compressibility.

Procedure: US Internal Jugular Vein Collapsibility Index measurment

US Inferior Vena Cava Collapsibility Index

EXPERIMENTAL

The transducer will be placed in the subxiphoid region in a longitudinal position. IVC measurements will be made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC will be identified by Doppler waveform, compressibility and phasic collapse with respiration.

Procedure: US Inferior Vena Cava Collapsibility Index measurment

Interventions

US Internal Jugular Vein Collapsibility Index measurment PROCEDURE

Machine A sonosite M-Turbo ultrasound machine will be used for all the examinations. A curvilinear USG probe for IVC imaging (1-5 MHz, 21 mm). The US transducer will be placed on the right side of the neck in the transverse plane over RIJV 2 cm above the sternoclavicular joint. The IJV will be identified by the color flow Doppler and compressibility. Care will be taken not to compress or obliterate the vein by applying minimal pressure. When the whole circumference of the vein will be visible the measurements were done. The recordings will be done for four respiratory cycles. The maximum, minimum AP diameters, and cross-sectional area will be estimated and, from this, corresponding CI will be derived (Maximum diameter or cross-sectional area (CSA)-minimum diameter or CSA/maximum diameter or CSA) ×100%. All the above measurements will be repeated with the head end of patients elevated to 30° position.

US Internal Jugular Vein Collapsibility Index

US Inferior Vena Cava Collapsibility Index measurment PROCEDURE

Machine A sonosite M-Turbo ultrasound machine will be used for all the examinations. A linear vascular transuder for IJV imaging (7-13 MHz, 38 mm) will be used. The transducer will be placed in the subxiphoid region in a longitudinal position. IVC measurements will be made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC will be identified by Doppler waveform, compressibility and phasic collapse with respiration. The maximum (IVCD) and minimum (IVCD) internal anteroposterior (AP) diameters of the IVC at the end of expiration and inspiration respectively over the same respiratory cycle will be measured. The IVCCI is derived from the equation, IVCCI= (IVCD max -IVCD min)/IVCD max × 100.

US Inferior Vena Cava Collapsibility Index

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients 2. aged 20-40 years 3.ASA Physical Status Class I and II 4. scheduled for elective lower segment cesarean section

You may not qualify if:

• Patients who will refuse
• Emergency LSCS
• Patients with expected massive intraoperative blood loss e.g. placenta Previa and placenta accreta
• Cardiovascular, respiratory, renal diseases
• Patients who will receive preloading of intravenous fluid

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: October 30, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share