Trial Outcomes & Findings for Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures (NCT NCT05870345)

Last Updated: 2024-06-20

Results Overview

FOR THE ACTIVE STUDY ONLY: Pocket-size ultrasound exam for each participant were interpreted as positive, negative or equivocal for signs of fracture. The feasibility study was not assessing for the presence or absence of fracture.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

1ED visit (1 day)

Results posted on

2024-06-20

Participant Flow

Participants were enrolled through a single emergency room from January 2022 through April 2023.

This study did not involved randomization. Patient were not randomized for this study. For both feasibility (N=22) and active (N=13) parts of this study, all participants who met inclusion criteria were enrolled. There was no crossover of participants of the two distinct parts of this study.

Unit of analysis: Images

Participant milestones

Participant milestones
Measure	Ultrasound Exam The Study consisted of two parts, a feasibility part and an active part. Participants in the feasibility part of the study only underwent a pocket-sized ultrasound exam and were a distinct (unique) group with no overlap or involvement with the active part. Each participant had 10 US images obtained. Participants in the active part of the study underwent a pocket-sized ultrasound exam and continued with normal clinically indicated medical care in the ED. The comparison to the ultrasound images was either a X-ray if fracture was suspected or bedside nursemaid reduction if subluxation was suspected (participants acted as their own comparison based on their routine ED clinical management). There was no participation overlap with the feasibility part. Each participant had 10 US images obtained.
Feasibility STARTED	22 440
Feasibility COMPLETED	22 440
Feasibility NOT COMPLETED	0 0
Active STARTED	13 260
Active COMPLETED	13 260
Active NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age of each participant was not obtained for feasibility part of study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasound Exam/Feasibility n=22 Participants Every participant will undergo a pocket-sized ultrasound exam. Both elbows were imaged. Age, gender, and race/ethnicity were not obtained or recorded.	Ultrasound Exam/Active n=13 Participants Every participant will undergo a pocket-sized ultrasound exam. The comparison to these images either a X-ray if fracture was suspected or beside nursemaid reduction if radial subluxation was suspected (participants acted as their own comparison based on their routine ED clinical management). Race/ethnicity were not obtained or recorded.	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=22 Participants	13 Participants n=13 Participants	35 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=22 Participants	0 Participants n=13 Participants	0 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=22 Participants	0 Participants n=13 Participants	0 Participants n=35 Participants
Age, Customized Age, Continuous Mean (Full Range)	—	7 years n=13 Participants • Age of each participant was not obtained for feasibility part of study.	7 years n=13 Participants • Age of each participant was not obtained for feasibility part of study.
Sex/Gender, Customized Sex/Gender Female (ACTIVE ONLY)	—	9 participants n=13 Participants • Gender was not obtained for the feasibility part of the study.	9 participants n=13 Participants • Gender was not obtained for the feasibility part of the study.
Sex/Gender, Customized Sex/Gender Male (ACTIVE ONLY)	—	4 participants n=13 Participants • Gender was not obtained for the feasibility part of the study.	4 participants n=13 Participants • Gender was not obtained for the feasibility part of the study.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	22 Participants n=22 Participants	13 Participants n=13 Participants	35 Participants n=35 Participants

PRIMARY outcome

Timeframe: 1ED visit (1 day)

Population: FOR THE ACTIVE STUDY ONLY: Images will be categorized as positive, negative or equivocal for signs of fracture. Pocket-sized US interpretation was compared to X-ray or performance of bedside nursemaid reduction as gold standard comparison. The feasibility study was not assessing for the presence or absence of fracture and did not have data analyzed for this outcome of the study.

Outcome measures

Outcome measures
Measure	Ultrasound Exam/Feasibility Every participant will undergo a pocket-sized ultrasound exam. Both elbows were imaged.	Ultrasound Exam/Active n=13 Participants Every participant will undergo a pocket-sized ultrasound exam. The comparison to these images either a X-ray if fracture was suspected or beside nursemaid reduction if radial subluxation was suspected (participants acted as their own comparison based on their routine ED clinical management). Race/ethnicity were not obtained or recorded.
Pocket Sized Ultrasound Elbow Exam Interpretation of Fracture Pocket-sized US interpretation · Positive Fracture at ED visit on US	—	8 Participants
Pocket Sized Ultrasound Elbow Exam Interpretation of Fracture Pocket-sized US interpretation · Negative Fracture at ED visit on US	—	5 Participants
Pocket Sized Ultrasound Elbow Exam Interpretation of Fracture X-ray or Nursemaid Reduction Outcome (Nursemaid reduction considered negative for fracture) · Positive Fracture at ED visit on US	—	7 Participants
Pocket Sized Ultrasound Elbow Exam Interpretation of Fracture X-ray or Nursemaid Reduction Outcome (Nursemaid reduction considered negative for fracture) · Negative Fracture at ED visit on US	—	6 Participants

SECONDARY outcome

Timeframe: Time period to complete since ultrasound exam per participant, approximately < 15 min

Population: In each part of the study, participants were enrolled and both elbows were imaged, with ten views of each elbow, resulting in 20 images per participant. As result the feasibility study had 440 images reviewed and the active study had 260 images.

Each participant in both the feasibility and active parts of the study underwent a pocket sized ultrasound exam. 10 ultrasound images were obtained of each elbow and both elbows were imaged. Images will deemed adequate or inadequate for interpretation.

Outcome measures

Outcome measures
Measure	Ultrasound Exam/Feasibility n=440 Images Every participant will undergo a pocket-sized ultrasound exam. Both elbows were imaged.	Ultrasound Exam/Active n=260 Images Every participant will undergo a pocket-sized ultrasound exam. The comparison to these images either a X-ray if fracture was suspected or beside nursemaid reduction if radial subluxation was suspected (participants acted as their own comparison based on their routine ED clinical management). Race/ethnicity were not obtained or recorded.
Ultrasound Exam Image Quality Adequate Image Quality	413 Images	258 Images
Ultrasound Exam Image Quality Inadequate Image Quality	27 Images	2 Images

Adverse Events

Ultrasound Exam/Feasibility

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultrasound Exam/Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alisa Brennan, Pediatric Emergency Medicine Fellow, Physician, Co-PI

University of CHicago

Phone: 9787585263

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place