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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
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pregnancy focused on measuring ultrasonography, emergency department

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

    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
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    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

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

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