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

NCT02584803 | Completed

• 1 other identifier: 103637
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypotension; Hypovolemic Shock

Outcome Measures

Primary Outcomes (1)

• Time to obtaining good Quality IVC images through RUQ and subxiphoid window

  60 seconds

Secondary Outcomes (3)

• Patient Acceptability of procedure

  10 seconds

• patient comfort

  10 seconds

• Ease of exam for the examiner

  10 seconds

Interventions

Ultrasound RADIATION

Evaluating the feasibility and efficacy of IVC ultrasound imaging through the RUQ and subxiphoid view in term parturients. 1. Patient Acceptability of procedure 2. Patient Comfort: 3. Ease of exam for the examiner

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Full term pregnant patient coming for elective cesarean section

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Science Centre

London, Ontario, Canada

Location

Related Publications (2)

• 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.

  PMID: 20202818 RESULT

• 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.

  PMID: 21315578 RESULT

MeSH Terms

Conditions

Hypotension; Shock

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Indu Singh

  Western University, Schulish school of Medicine, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 23, 2015
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 11, 2018

Record last verified: 2016-05

Locations

CA (1)