Trial Outcomes & Findings for Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections (NCT NCT00595881)

Results Overview

The sensitivity and specificity of clinical examination with the addition of bedside emergency ultrasound will be compared against that of clinical examination alone.The number of lesions determined to actually have a drainable fluid collection will serve as the denominator in the calculation of sensitivity, and the number of lesions correctly identified as having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator.The number of lesions determined to not have a drainable fluid collection will serve as the denominator in the calculation of specificity, and the number of lesions correctly identified as not having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator. Significance will be defined as a 95% confidence interval surrounding the differences between the two groups for sensitivity and specificity that does not include 0.

Recruitment status

COMPLETED

Target enrollment

420 participants

Primary outcome timeframe

18 mos

Results posted on

2012-12-31

Participant Flow

Patients were recruited over a 22 month period

Participant milestones

Participant milestones
Measure	Ultrasound One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
Overall Study STARTED	420
Overall Study COMPLETED	420
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasound n=420 Participants One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
Age, Categorical <=18 years	420 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	7.8 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	218 Participants n=5 Participants
Sex: Female, Male Male	202 Participants n=5 Participants
Region of Enrollment United States	420 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 mos

Population: Assuming a baseline sensitivity of clinical exam alone similar to that previously published (86%), type 1 error rate 0.05, and intraclass correlation coefficient of 0.5 for lesions within patients, we estimated a sample size of 393 lesions would provide 80% power to detect at least a 9% difference in the sensitivity of CE+EUS compared to CE alone.

The sensitivity and specificity of clinical examination with the addition of bedside emergency ultrasound will be compared against that of clinical examination alone.The number of lesions determined to actually have a drainable fluid collection will serve as the denominator in the calculation of sensitivity, and the number of lesions correctly identified as having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator.The number of lesions determined to not have a drainable fluid collection will serve as the denominator in the calculation of specificity, and the number of lesions correctly identified as not having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator. Significance will be defined as a 95% confidence interval surrounding the differences between the two groups for sensitivity and specificity that does not include 0.

Outcome measures

Outcome measures
Measure	Clinical Exam Alone n=420 Participants Patients will have data collected from their clinical examination alone	Clinical Exam+ Ultrasound n=420 Participants Patients will have data collected following the addition of a bedside ultrasound performed to the clinical exam.
Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone. Sensitivity	94.7 Ratio as a percentage Interval 90.2 to 97.9	93.1 Ratio as a percentage Interval 88.6 to 97.0
Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone. Specificity	84.2 Ratio as a percentage Interval 74.7 to 91.7	81.4 Ratio as a percentage Interval 70.8 to 90.3

Adverse Events

Ultrasound

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

Jennifer Marin

Children's Hospital of Pittsburgh

Phone: 412-692-7692

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place