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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268877
• Other study ID #: 11-1444
• Status: Completed
• Phase: N/A
• First received: October 16, 2014
• Last updated: August 4, 2016
• Start date: March 2013
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Emergencies
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	United States Naval Medical Center, Portsmouth, United States Naval Medical Center, San Diego, University of Colorado, Denver

References & Publications (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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Emergency Department Length-of-Stay	The time the patient is placed in room to the time that the patient is discharged/admitted.	48 hours	No
Secondary	Patient Satisfaction	Patient satisfaction assessed via self-report at end of emergency department stay	48 hours	No
Secondary	BMI	Height and weight measurements self-reported by patient during emergency department stay	48 hours	No
Secondary	Time from definitive diagnosis to emergency department discharge	The time that a definitive diagnosis is recorded in patient chart to the time the patient is discharged from the emergency department	48 hours	No