Inferior Vena Cava (IVC) Diameters Before & After Interscalene Block

IVC - Inferior Vena Cava Abnormality Clinical Trial

Official title:

Evaluating the Mechanism of Changes to Inferior Vena Cava Diameter Using Point of Care Ultrasound in Patients Undergoing Interscalene Brachial Plexus Block

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03989076
• Other study ID #: UCSD 181482
• Status: Withdrawn
• Start date: April 12, 2019
• Est. completion date: July 14, 2021

Study information

• Verified date: July 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to understand how changes to breathing patterns in the chest affect blood flow to the heart from the inferior vena cava in the abdomen. Ultrasound of the upper abdomen will be used to visualize changes in breathing patterns in the chest and blood flow in the abdomen.

Description:

In recent practice, point-of-care ultrasound has been used to assess the size and respiratory variation of the inferior vena cava as a marker for volume status and fluid responsiveness. Little investigation has occurred regarding the mechanism of observed respiratory variation. Anesthetic plans for surgery (e.g. shoulder replacement) frequently employ interscalene injections to target and block the brachial plexus, which (on the same side) results in phrenic nerve palsy and paralysis of the diaphragm. The goal of this study is to examine the relationship between diaphragmatic function and variation in IVC diameter. Specifically, the investigators will evaluate and compare the size and variability of the inferior vena cava by point-of-care ultrasound before and after brachial plexus block.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 14, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (age > 18 years)
• Scheduled to receive an interscalene block

Exclusion Criteria:

• Any person with known, pre-existing phrenic nerve, diaphragmatic, or inferior vena cava anomaly.
• Patients who cannot be successfully imaged by ultrasound or who cannot participate in spirometry will additionally be excluded.
• Non-English speaking patients will be excluded as well as there is no research funding to translate consent forms. Given that there is no potential benefit to participation in the study, this does not exclude these individuals from any potentially beneficial therapy.

Related Conditions & MeSH terms

• Congenital Abnormalities
• IVC - Inferior Vena Cava Abnormality

Intervention

Procedure:
• Interscalene Brachial Plexus Block
Analgesic nerve block as part of routine care with pre- and post-block ultrasonographic imaging of the diaphragm and inferior vena cava

Locations

Country	Name	City	State
United States	UCSD Medical Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (7)

Boon AJ, Sekiguchi H, Harper CJ, Strommen JA, Ghahfarokhi LS, Watson JC, Sorenson EJ. Sensitivity and specificity of diagnostic ultrasound in the diagnosis of phrenic neuropathy. Neurology. 2014 Sep 30;83(14):1264-70. doi: 10.1212/WNL.0000000000000841. Epub 2014 Aug 27. — View Citation

El-Boghdadly K, Chin KJ, Chan VWS. Phrenic Nerve Palsy and Regional Anesthesia for Shoulder Surgery: Anatomical, Physiologic, and Clinical Considerations. Anesthesiology. 2017 Jul;127(1):173-191. doi: 10.1097/ALN.0000000000001668. Review. — View Citation

Feissel M, Michard F, Faller JP, Teboul JL. The respiratory variation in inferior vena cava diameter as a guide to fluid therapy. Intensive Care Med. 2004 Sep;30(9):1834-7. Epub 2004 Mar 25. — View Citation

Gignon L, Roger C, Bastide S, Alonso S, Zieleskiewicz L, Quintard H, Zoric L, Bobbia X, Raux M, Leone M, Lefrant JY, Muller L. Influence of Diaphragmatic Motion on Inferior Vena Cava Diameter Respiratory Variations in Healthy Volunteers. Anesthesiology. 2016 Jun;124(6):1338-46. doi: 10.1097/ALN.0000000000001096. — View Citation

Kimura BJ, Dalugdugan R, Gilcrease GW 3rd, Phan JN, Showalter BK, Wolfson T. The effect of breathing manner on inferior vena caval diameter. Eur J Echocardiogr. 2011 Feb;12(2):120-3. doi: 10.1093/ejechocard/jeq157. Epub 2010 Oct 27. — View Citation

Magder S. Bench-to-bedside review: An approach to hemodynamic monitoring--Guyton at the bedside. Crit Care. 2012 Oct 29;16(5):236. doi: 10.1186/cc11395. Review. — View Citation

Nagdev AD, Merchant RC, Tirado-Gonzalez A, Sisson CA, Murphy MC. Emergency department bedside ultrasonographic measurement of the caval index for noninvasive determination of low central venous pressure. Ann Emerg Med. 2010 Mar;55(3):290-5. doi: 10.1016/j.annemergmed.2009.04.021. Epub 2009 Jun 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ipsilateral hemiparesis	Detectable paralysis of the ipsilateral hemidiaphragm by point of care ultrasound	Within 30 minutes post-block
Primary	IVC Collapsibility Index Change	Measured IVC diameter and collapsibility by point of care ultrasound	Within 30 minutes post-block