A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography
Primary Purpose
Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Emergency Medicine Physician Ultrasound
Ultrasound
Sponsored by

About this trial
This is an interventional health services research trial for Pregnancy focused on measuring ultrasonography, emergency department
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Emergency Medicine Physician Ultrasound
Radiology Tech Ultrasound
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Emergency Department Length-of-Stay
The time the patient is placed in room to the time that the patient is discharged/admitted.
Secondary Outcome Measures
Full Information
NCT ID
NCT02268877
First Posted
October 16, 2014
Last Updated
June 1, 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
1. Study Identification
Unique Protocol Identification Number
NCT02268877
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
United States Naval Medical Center, Portsmouth, United States Naval Medical Center, San Diego, University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
ultrasonography, emergency department
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emergency Medicine Physician Ultrasound
Arm Type
Experimental
Arm Description
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.
Arm Title
Radiology Tech Ultrasound
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Emergency Medicine Physician Ultrasound
Intervention Description
An ultrasound will be performed by an emergency medicine resident or attending physician
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
An ultrasound will be performed by a radiology department technician
Primary Outcome Measure Information:
Title
Time to Definitive Diagnosis
Description
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
Time Frame
24 hours
Title
Emergency Department Length-of-Stay
Description
The time the patient is placed in room to the time that the patient is discharged/admitted.
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kendall, MD
Organizational Affiliation
Denver Health and Hospital Authority
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17446770
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.
Results Reference
result
PubMed Identifier
9055772
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.
Results Reference
result
PubMed Identifier
9715242
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.
Results Reference
result
PubMed Identifier
10036346
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.
Results Reference
result
PubMed Identifier
15347539
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.
Results Reference
result
PubMed Identifier
11043992
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.
Results Reference
result
PubMed Identifier
9055773
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.
Results Reference
result
Learn more about this trial
A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography
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