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

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02584803
Collaborator
(none)
30
1
16
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Inferior Vena Cava Assessment in Term Pregnancy Using Ultrasound: a Feasibility Study of Subxiphoid and RUQ Views
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Outcome Measures

Primary Outcome Measures

  1. Time to obtaining good Quality IVC images through RUQ and subxiphoid window [60 seconds]

Secondary Outcome Measures

  1. Patient Acceptability of procedure [10 seconds]

    Would you agree to have similar ultrasound scans again? Yes/No

  2. patient comfort [10 seconds]

    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

  3. Ease of exam for the examiner [10 seconds]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 London Health Science Centre London Ontario Canada

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

  • Principal Investigator: Indu Singh, Western University, Schulish school of Medicine, Department of Anesthesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT02584803
Other Study ID Numbers:
  • 103637
First Posted:
Oct 23, 2015
Last Update Posted:
Dec 11, 2018
Last Verified:
May 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 11, 2018