Clinical trial NCT02268877: A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography
Official title: A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: ultrasonography
emergency department
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: United States Naval Medical Center, Portsmouth
name: United States Naval Medical Center, San Diego
name: University of Colorado, Denver
First posted: 2014-10-20
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Time to Definitive Diagnosis
timeFrame: 24 hours
measure: Emergency Department Length-of-Stay
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Denver Health and Hospital Authority
name: John Kendall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.