A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography

NCT02268877 | Completed Results

• 1 other identifier: 11-1444
• Study Type: interventional
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this project is to compare the efficiency of pelvic ultrasounds performed by emergency medicine residents and attending physicians to the efficiency of pelvic ultrasounds performed by the department of radiology.

Conditions

Pregnancy

Keywords

ultrasonography; emergency department

Outcome Measures

Primary Outcomes (2)

• Time to Definitive Diagnosis

  The time the patient is placed in room to the time that results of the ultrasound (and/or consultative impression made by radiology or obstetrics and gynecology) are documented in patient chart

  24 hours

• Emergency Department Length-of-Stay

  The time the patient is placed in room to the time that the patient is discharged/admitted.

  48 hours

Study Arms (2)

Emergency Medicine Physician Ultrasound

EXPERIMENTAL

Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.

Other: Emergency Medicine Physician Ultrasound; Device: Ultrasound

Radiology Tech Ultrasound

ACTIVE COMPARATOR

Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.

Device: Ultrasound

Interventions

Emergency Medicine Physician Ultrasound OTHER

An ultrasound will be performed by an emergency medicine resident or attending physician

Emergency Medicine Physician Ultrasound

Ultrasound DEVICE

An ultrasound will be performed by a radiology department technician

Emergency Medicine Physician Ultrasound; Radiology Tech Ultrasound

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• have a positive serum or urine beta-human chorionic gonadotropin (hCG)
• estimated gestational age (EGA) of less than 20 weeks
• complaint of pelvic pain and/or vaginal bleeding

You may not qualify if:

• prior known documentation of an intrauterine pregnancy
• estimated gestational age (EGA) of greater than 20 weeks
• peritoneal findings on physical examination
• unstable vital signs as deemed appropriate by the attending physician
• prisoners
• open cervix upon physical examination

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• United States Naval Medical Center, Portsmouth: collaborator
• United States Naval Medical Center, San Diego: collaborator
• University of Colorado, Denver: collaborator

Related Publications (7)

• Kendall JL, Hoffenberg SR, Smith RS. History of emergency and critical care ultrasound: the evolution of a new imaging paradigm. Crit Care Med. 2007 May;35(5 Suppl):S126-30. doi: 10.1097/01.CCM.0000260623.38982.83.

  PMID: 17446770 RESULT

• Durham B, Lane B, Burbridge L, Balasubramaniam S. Pelvic ultrasound performed by emergency physicians for the detection of ectopic pregnancy in complicated first-trimester pregnancies. Ann Emerg Med. 1997 Mar;29(3):338-47. doi: 10.1016/s0196-0644(97)70345-7.

  PMID: 9055772 RESULT

• Burgher SW, Tandy TK, Dawdy MR. Transvaginal ultrasonography by emergency physicians decreases patient time in the emergency department. Acad Emerg Med. 1998 Aug;5(8):802-7. doi: 10.1111/j.1553-2712.1998.tb02507.x.

  PMID: 9715242 RESULT

• Dart RG. Role of pelvic ultrasonography in evaluation of symptomatic first-trimester pregnancy. Ann Emerg Med. 1999 Mar;33(3):310-20. doi: 10.1016/s0196-0644(99)70368-9.

  PMID: 10036346 RESULT

• Tayal VS, Cohen H, Norton HJ. Outcome of patients with an indeterminate emergency department first-trimester pelvic ultrasound to rule out ectopic pregnancy. Acad Emerg Med. 2004 Sep;11(9):912-7. doi: 10.1197/j.aem.2004.03.017.

  PMID: 15347539 RESULT

• Blaivas M, Sierzenski P, Plecque D, Lambert M. Do emergency physicians save time when locating a live intrauterine pregnancy with bedside ultrasonography? Acad Emerg Med. 2000 Sep;7(9):988-93. doi: 10.1111/j.1553-2712.2000.tb02088.x.

  PMID: 11043992 RESULT

• Shih CH. Effect of emergency physician-performed pelvic sonography on length of stay in the emergency department. Ann Emerg Med. 1997 Mar;29(3):348-51; discussion 352. doi: 10.1016/s0196-0644(97)70346-9.

  PMID: 9055773 RESULT

MeSH Terms

Conditions

Emergencies

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

This is not a blinded study. As such the performers may have been biased to complete these procedures more quickly than they would be if the study were not taking place.

Results Point of Contact

• Title: Dr. John Kendall
• Organization: Denver Health and Hospital Authority

John.Kendall@dhha.org

(303)602-5187

Study Officials

• John Kendall, MD

  Denver Health and Hospital Authority

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 20, 2014
• Study Start: March 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 27, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share