Inferior Vena Cava Assessment in Term Pregnancy Using Ultrasound: a Feasibility Study of Subxiphoid and RUQ Views

This study is to assess the feasibility of 2 different ultrasound views of the inferior vena cava (IVC), a large vein that returns blood to the heart. Ultrasound is safe in pregnancy and, is regularly used to evaluate the fetus. It is hoped that imaging of the IVC will then allow us to determine the fluid status of the parturient which could be helpful in treating hemodynamic instability. This study will not involve any change in management of the participating patients.

Study Overview

• Status: Completed
• Conditions: Hypotension; Hypovolemic Shock
• Intervention / Treatment: Radiation: Ultrasound

Detailed Description

Anesthesiology consultants and trainees with US experience will first perform scans from the RUQ view starting on the mid-axillary line at the T4 intercostal space, looking to obtain a view of the IVC as it enters the right atrium (RA). Following successful acquisition, the examiner will perform scan from the subxiphoid position, looking to obtain the same view of the IVC transitioning into the RA. Primary endpoint will be time to obtaining quality of images. The investigator will use a stopwatch to time acquisition of images. If the duration of scanning exceeds ten minutes, the scan will be discontinued and labeled as failed. Each image will be separately reviewed by 2 different US specialists with extensive US experience. Images will be assessed according to a Likert scale from 1 to 5. (Very poor (1), poor (2), acceptable (3), good (4), very good (5)) Secondary endpoints will be assessed as follows: 1. Acceptability: all patients participating in the study will complete a questionnaire to assess acceptability. 2. Comfort: During the exam the patient will have the option to suspend the scan by stating they are uncomfortable and wish to stop. Each request will be noted and taken into the account at data analysis. Furthermore, patients will be given a questionnaire at the end of the scan and asked to rate their comfort level during procedure according to Likert scale. (Very comfortable (5), comfortable (4), equivocal (3), uncomfortable (2), very uncomfortable (1)) 3. Ease of exam: Examiner will rate the ease of image acquirement according to Likert scale. (impossible (1), difficult (2), equivocal (3), easy (4), very easy (5))

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • London Health Science Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Full term pregnant patient coming for elective cesarean section

Description

Inclusion Criteria:

• Adults pregnant females,
• Age 18-45,
• Term pregnancy Parturients not in established labor Singleton pregnancies

Exclusion Criteria:

• Advanced labor,
• Multiple gestations,
• Maternal or fetal distress,
• BMI > 45.
• Inability to obtain informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to obtaining good Quality IVC images through RUQ and subxiphoid window	60 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Acceptability of procedure	Would you agree to have similar ultrasound scans again? Yes/No	10 seconds
patient comfort	Please rate your comfort during the ultrasound scan, on a scale of 1 to 5. Where 5 is very comfortable and 0 is not comfortable	10 seconds
Ease of exam for the examiner	Ease of exam: Examiner will rate the ease of image acquirement according to Likert scale. (impossible (1), difficult (2), equivocal (3), easy (4), very easy (5)	10 seconds

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Indu Singh, Western University, Schulish school of Medicine, Department of Anesthesia

Publications and helpful links

General Publications

• Dennis A, Arhanghelschi I, Simmons S, Royse C. Prospective observational study of serial cardiac output by transthoracic echocardiography in healthy pregnant women undergoing elective caesarean delivery. Int J Obstet Anesth. 2010 Apr;19(2):142-8. doi: 10.1016/j.ijoa.2009.06.007. Epub 2010 Mar 3.
• Dennis AT. Transthoracic echocardiography in obstetric anaesthesia and obstetric critical illness. Int J Obstet Anesth. 2011 Apr;20(2):160-8. doi: 10.1016/j.ijoa.2010.11.007. Epub 2011 Feb 18.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Shock; Hypotension; Hypovolemia
• Other Study ID Numbers: 103637

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED