Can Subclavian / Infraclavicular Axillary Vein Collapsibility Index Predict Post-Spinal Hypotension in Caesarean Section Operations? (Cesarean)

Subclavian / Infraclavicular Axillary Vein Collapsibility Index in Pregnant Patients

Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3% to 33%, which may result in organ hypoperfusion and ischemic events (1,2). In pregnant patients, this incidence may increase to 70% and severe PSH may increase the risk of maternal and fetal complications (3). Therefore, it is important for anesthesiologists to estimate the incidence of PSH in cesarean sections and to identify possible mechanisms (4).

One of the important factors affecting the susceptibility of patients to intraoperative hypotension is the preoperative intravascular volume status. Recently, ultrasonography of the central veins has been used frequently by anesthesiologists in the preoperative period in order to evaluate the intravascular volume status (5). Salama and Elkashlan stated that the collapsibility index of the inferior vena cava is a new predictive value for PSH (6). Choi et al. showed that the subclavian vein or infraclavicular axillary vein collapsibility index is an important predictive value for hypotension after induction of general anesthesia (7).

In this study, we wanted to investigate whether the subclavian vein or infraclavicular axillary vein collapsibility index can be used as a predictive value for PSH in cesarean section.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Spinal Hypotension

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Emine ASLANLAR, assis. prof.; Phone Number: 05556219830; Email: draslanlar@gmail.com
• Study Contact Backup: Name: Mehmet SARGIN, assoc. prof.; Phone Number: 05322662766; Email: mehmet21sargin@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

ASA I-II physical status patients scheduled for cesarean section under spinal anesthesia

Description

Inclusion Criteria:

• Spinal anesthesia
• ceserean operation
• American Society of Anesthesiologists' (ASA) physical status I-II

Exclusion Criteria:

• Patients who underwent cesarean section in emergency conditions
• Patients who underwent cesarean section under general anesthesia
• American Society of Anesthesiologists' (ASA) physical status III-IV

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of Subclavian / Infraclavicular Axillary Vein Collapsibility Index for detecting Postspinal hypotension	Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3 to 33% that may result in organ hypoperfusion and ischaemic events. This incidence is higher in pregnant women with a rate of 70%. Measurement of the IVC diameter and its collapsibility index before spinal anaesthesia has been shown to be a good predictive value of the occurrence of PSH. A previous study showed an acceptable correlation between the collapsibility of SCV (SCV-CI) and collapsibility of IVC (IVC-CI) in surgical and intensive care patients. In this study, we measured the preoperative collapsibility index of the SCV or the infraclavicular axillary vein during respiratory variation, and then examined whether these parameters could predict hypotension after spinal anaesthesia in patients undergoing ceserean	45 min

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Emine ASLANLAR, assis. prof., selcuk univercity medical faculty

Study record dates

Study Major Dates

• Study Start (Anticipated): November 8, 2021
• Primary Completion (Anticipated): January 24, 2022
• Study Completion (Anticipated): March 2, 2022

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: post spinal hypotension, the subclavian vein or infraclavicular axillary vein collapsibility index
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: SCV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No