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

• ClinicalTrials.gov Identifier: NCT02268877
• Recruitment Status: Completed
• First Posted: October 20, 2014
• Results First Posted: May 31, 2017
• Last Update Posted: June 27, 2017
• Sponsor: Denver Health and Hospital Authority
• Collaborators: United States Naval Medical Center, Portsmouth; United States Naval Medical Center, San Diego; University of Colorado, Denver
• Information provided by (Responsible Party): Denver Health and Hospital Authority

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy	Other: Emergency Medicine Physician Ultrasound; Device: Ultrasound	Not Applicable

Detailed Description:

This study is a randomized, prospective interventional study of pregnant patients presenting to the emergency department with complaints of pelvic pain and/or vaginal bleeding. This study will be conducted at 4 sites across the United States. Patients who are eligible and consent to participate will be randomized to one of two conditions; 1) a pelvic ultrasound that is performed by a certified emergency department attending or physician, or 2) a pelvic ultrasound that is performed by a certified radiology technician (standard-of-care). The time to diagnosis and emergency department length of stay between the two groups will be compared.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Open Label
• Primary Purpose: Health Services Research
• Official Title: A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography
• Study Start Date: March 2013
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: March 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Emergency Medicine Physician Ultrasound; 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; An ultrasound will be performed by an emergency medicine resident or attending physician; Device: Ultrasound; An ultrasound will be performed by a radiology department technician
Active Comparator: Radiology Tech Ultrasound; 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; An ultrasound will be performed by a radiology department technician

Outcome Measures

Primary Outcome Measures :

1. Time to Definitive Diagnosis [ Time Frame: 24 hours ]
   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
2. Emergency Department Length-of-Stay [ Time Frame: 48 hours ]
   The time the patient is placed in room to the time that the patient is discharged/admitted.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Sponsors and Collaborators

Denver Health and Hospital Authority

United States Naval Medical Center, Portsmouth

United States Naval Medical Center, San Diego

University of Colorado, Denver

Investigators

• Principal Investigator: John Kendall, MD; Denver Health and Hospital Authority

More Information

Publications of Results:

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.

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.

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.

Dart RG. Role of pelvic ultrasonography in evaluation of symptomatic first-trimester pregnancy. Ann Emerg Med. 1999 Mar;33(3):310-20. Review.

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.

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.

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.

• Responsible Party: Denver Health and Hospital Authority
• ClinicalTrials.gov Identifier: NCT02268877
• Other Study ID Numbers: 11-1444
• First Posted: October 20, 2014
• Results First Posted: May 31, 2017
• Last Update Posted: June 27, 2017
• Last Verified: June 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Denver Health and Hospital Authority:

ultrasonography; emergency department

Additional relevant MeSH terms:

Emergencies; Disease Attributes; Pathologic Processes