NCT03989076

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

June 13, 2019

Last Update Submit

July 14, 2021

Conditions

IVC - Inferior Vena Cava Abnormality

Outcome Measures

Primary Outcomes (2)

  • Ipsilateral hemiparesis

    Detectable paralysis of the ipsilateral hemidiaphragm by point of care ultrasound

    Within 30 minutes post-block

  • IVC Collapsibility Index Change

    Measured IVC diameter and collapsibility by point of care ultrasound

    Within 30 minutes post-block

Interventions

Interscalene Brachial Plexus BlockPROCEDURE

Analgesic nerve block as part of routine care with pre- and post-block ultrasonographic imaging of the diaphragm and inferior vena cava

Also known as: Point of Care Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult (age \> 18 years) patients undergoing surgery of any type at UC San Diego Medical Center for whom the surgeon has requested an interscalene nerve block and for whom the block is clinically indicated as determined by the primary anesthesiologist.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Medical Center

La Jolla, California, 92037, United States

Location

Related Publications (7)

  • 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.

    PMID: 19556029BACKGROUND

  • 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. doi: 10.1007/s00134-004-2233-5. Epub 2004 Mar 25.

    PMID: 15045170BACKGROUND

  • 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.

    PMID: 23106914BACKGROUND

  • 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.

    PMID: 20980326BACKGROUND

  • 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.

    PMID: 27003619BACKGROUND

  • 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.

    PMID: 28514241BACKGROUND

  • 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.

    PMID: 25165390BACKGROUND
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Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 18, 2019

Study Start

April 12, 2019

Primary Completion

July 14, 2021

Study Completion

July 14, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

US(1)