Trial Outcomes & Findings for A Randomized Prospective Analysis of Time to Diagnosis and Length of Stay of Emergency Department Pelvic Ultrasonography (NCT NCT02268877)
NCT ID: NCT02268877
Last Updated: 2017-06-27
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
224 participants
Primary outcome timeframe
24 hours
Results posted on
2017-06-27
Participant Flow
Participant milestones
| Measure |
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.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician
|
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.
Ultrasound: An ultrasound will be performed by a radiology department technician
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
111
|
|
Overall Study
COMPLETED
|
118
|
106
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Emergency Medicine Physician Ultrasound
n=118 Participants
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.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician
|
Radiology Tech Ultrasound
n=106 Participants
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.
Ultrasound: An ultrasound will be performed by a radiology department technician
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
n=118 Participants
|
26 years
n=106 Participants
|
26 years
n=224 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=118 Participants
|
106 Participants
n=106 Participants
|
224 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=118 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=224 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
118 participants
n=118 Participants
|
106 participants
n=106 Participants
|
224 participants
n=224 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe 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
Outcome measures
| Measure |
Emergency Medicine Physician Ultrasound
n=118 Participants
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.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician
|
Radiology Tech Ultrasound
n=106 Participants
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.
Ultrasound: An ultrasound will be performed by a radiology department technician
|
|---|---|---|
|
Time to Definitive Diagnosis
|
87 minutes
Interval 40.0 to 179.0
|
136 minutes
Interval 99.0 to 169.0
|
PRIMARY outcome
Timeframe: 48 hoursThe time the patient is placed in room to the time that the patient is discharged/admitted.
Outcome measures
| Measure |
Emergency Medicine Physician Ultrasound
n=118 Participants
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.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician
|
Radiology Tech Ultrasound
n=106 Participants
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.
Ultrasound: An ultrasound will be performed by a radiology department technician
|
|---|---|---|
|
Emergency Department Length-of-Stay
|
181 minutes
Interval 110.0 to 255.0
|
201 minutes
Interval 171.0 to 257.0
|
Adverse Events
Emergency Medicine Physician Ultrasound
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Radiology Tech Ultrasound
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Emergency Medicine Physician Ultrasound
n=118 participants at risk
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.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician
|
Radiology Tech Ultrasound
n=106 participants at risk
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.
Ultrasound: An ultrasound will be performed by a radiology department technician
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
ectopic pregnancy
|
1.7%
2/118 • Number of events 2 • Adverse event data was collected for 72 hours after receipt of the intervention.
Ectopic pregnancies and intrauterine fetal demise are expected in the given study population, and have been deemed unrelated to the research intervention by the Principal Investigator.
|
1.9%
2/106 • Number of events 2 • Adverse event data was collected for 72 hours after receipt of the intervention.
Ectopic pregnancies and intrauterine fetal demise are expected in the given study population, and have been deemed unrelated to the research intervention by the Principal Investigator.
|
Other adverse events
| Measure |
Emergency Medicine Physician Ultrasound
n=118 participants at risk
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.
Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician
Ultrasound: An ultrasound will be performed by a radiology department technician
|
Radiology Tech Ultrasound
n=106 participants at risk
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.
Ultrasound: An ultrasound will be performed by a radiology department technician
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
intrauterine fetal demise
|
3.4%
4/118 • Number of events 4 • Adverse event data was collected for 72 hours after receipt of the intervention.
Ectopic pregnancies and intrauterine fetal demise are expected in the given study population, and have been deemed unrelated to the research intervention by the Principal Investigator.
|
1.9%
2/106 • Number of events 2 • Adverse event data was collected for 72 hours after receipt of the intervention.
Ectopic pregnancies and intrauterine fetal demise are expected in the given study population, and have been deemed unrelated to the research intervention by the Principal Investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place