NCT02697747

Brief Summary

The investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4 interspace will improve resident's long term skill to correctly identify the interspace as compared to palpation alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

5.1 years

First QC Date

November 16, 2015

Last Update Submit

September 25, 2021

Conditions

Healthy

Keywords

UltrasoundPalpationAnalgesiaEpidural

Outcome Measures

Primary Outcomes (1)

  • Accuracy measured as percentage of cases where the L3-4 vertebral interspace is identified correctly

    Percentage of cases where the L3-4 vertebral interspace is identified correctly

    1 month

Secondary Outcomes (1)

  • Durability measured as percentage of cases where the L3-4 vertebral interspace is identified correctly

    6 months and 12 months

Study Arms (1)

Ultrasound education

Training in the use of ultrasound to identify the L3-L4 interspace

Other: Education

Interventions

EducationOTHER

Educational intervention in the use of ultrasound to identify landmarks

Ultrasound education

Eligibility Criteria

Age12 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant female patients.

You may qualify if:

  • term gestation (at least 38 weeks gestation)

You may not qualify if:

  • Prior back surgery
  • Previously diagnosed skeletal deformities such as scoliosis
  • BMI greater than 40
  • Height less than 60 inches
  • Patient discomfort requiring immediate analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Philip E Hess, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

November 16, 2015

First Posted

March 3, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2020

Study Completion

August 1, 2021

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)