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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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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))

Conditions

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Hypotension Hypovolemic Shock

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Ultrasound

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Indu Singh

Role: PRINCIPAL_INVESTIGATOR

Western University, Schulish school of Medicine, Department of Anesthesia

Locations

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London Health Science Centre

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT

PMID: 20202818 (View on PubMed)

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.