NCT03121794

Brief Summary

Evaluate whether discrete landmarks of the proximal humerus can be identified using ultrasound in patients with various body habitus and BMI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Typical duration 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

First Submitted

Initial submission to the registry

March 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2020

Completed
Last Updated

September 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2.6 years

First QC Date

March 23, 2017

Last Update Submit

September 16, 2020

Conditions

Proximal Humerus Interosseous Venous AccessAnatomic LandmarkUltrasonography

Keywords

ultrasonographyIntraosseous Vascular accesshumerusanatomic landmark

Outcome Measures

Primary Outcomes (1)

  • Number of proximal humerus landmarks successfully identified by ultrasound exam

    Two investigators will perform an ultrasonographic exam on each patient, with one investigator examining each side of the body. Each investigator will aim to identify 6 anatomical landmarks: 1. The humeral shaft, 2. The surgical neck of the humerus, 3. The lesser tubercle, 4. The greater tubercle, 5. The intertubercular sulcus 6. The target site in the greater tubercle for needle insertion. Each side will receive a score ranging from 0 to 6 corresponding to the number of landmarks correctly identified.

    Through completion of ultrasonographic exam, an average of 30 minutes.

Secondary Outcomes (2)

  • Time used to identify all 6 anatomical landmarks using ultrasound in seconds.

    Through completion of ultrasonographic exam, an average of 30 minutes.

  • Depth of each landmark from the skin in centimeters.

    Through completion of ultrasonographic exam, an average of 30 minutes.

Study Arms (3)

Low BMI

Ultrasonographic identification of proximal humerus landmarks for patients with BMI 18.5 - 25 kg/m2

Procedure: Ultrasonographic examDevice: ultrasound machine

Moderate BMI

Ultrasonographic identification of proximal humerus landmarks for patients with BMI 30-35 kg/m2 will receive ultrasound exam.

Procedure: Ultrasonographic examDevice: ultrasound machine

High BMI

Ultrasonographic identification of proximal humerus landmarks for patients with BMI \> 40 kg/m2 will receive ultrasound exam.

Procedure: Ultrasonographic examDevice: ultrasound machine

Interventions

Ultrasonographic examPROCEDURE

The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks

High BMILow BMIModerate BMI
ultrasound machineDEVICE

Regular ultrasound machine used at Cleveland Clinic

High BMILow BMIModerate BMI

Eligibility Criteria

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

Participants will be selected after chart review of current patients undergoing general, cardiac, thoracic, or vascular surgery. Patients will be approached in the preoperative clinic or during their hospitalization (preoperatively or postoperatively). Informed consent will be obtained prior to performing the study. Participants will be separated into 3 cohorts based on BMI. The number of participants in each cohort is as follows: 10 patients with BMI 18.5 - 25 kg/m2; 10 patients with BMI 30-35 kg/m2, 10 patients with BMI \> 40 kg/m2.

You may qualify if:

  • Males or females 18 years of age or older undergoing general, cardiac, thoracic or vascular surgery.
  • BMI \>= 18.5 kg/m\^2

You may not qualify if:

  • Limited mobility/ range of motion of arms
  • Prior surgical intervention on shoulder or humerus
  • History of arm dislocation with internal rotation
  • History of arm fracture
  • BMI in ranges: 25.1 - 29.9, 35.1 - 39.9

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Design

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

Study Record Dates

First Submitted

March 23, 2017

First Posted

April 20, 2017

Study Start

April 1, 2017

Primary Completion

October 19, 2019

Study Completion

July 7, 2020

Last Updated

September 18, 2020

Record last verified: 2020-08

Locations

US(1)