MedTrace Logo

A Factorial Trial of Ultrasound and Manometry to Improve the Success of Thoracic Epidural Placement

NCT03559023 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2020-03-03

No results posted yet for this study

Summary

To investigate the use of ultrasound and manometry to increase the success rate of thoracic epidural placement. The use of ultrasound for lumbar epidural catheter placement is well established and is thought to assist in identifying an optimal skin entry point, depth to lamina and ligamentum flavum, and needle trajectory. The use of sterile manometry tubing to demonstrate a falling and oscillating fluid column has been described as a confirmatory test in the placement of lumbar epidurals. This study will determine if the efficacy of thoracic epidural placement is improved if placement is performed with the use of either US, or manometry, or both techniques combined, compared with a standard landmark-based placement technique alone.

Conditions

  • Surgery

Interventions

PROCEDURE

Ultrasound Only

The anesthesia team will use ultrasound to scan on subject's upper back (thoracic spine) to identify a place to begin the epidural procedure. A pen will be used to place markings on subject's back.

PROCEDURE

Manometry Only

The anesthesia team will use an extra piece of tubing to confirm the epidural space one the epidural space is established.

PROCEDURE

Ultrasound Plus Manometry

The anesthesia team will use both ultrasound and manometry to assist with epidural placement.

PROCEDURE

Usual Care/Management

The epidural will be placed using the usual technique utilized by the anesthesiology department. The the usual care/management group will receive a sham ("fake") ultrasound exam of subject's upper back with fake pen markings placed on subject's back. The ultrasound machine will not be turned on.

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Ryan Ivie, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2020-08-30
Completion
2020-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03559023 on ClinicalTrials.gov