Trial Outcomes & Findings for Diagnostic Use of Lung Ultrasound for Suspected Pneumonia in Nepal (NCT NCT02949141)
NCT ID: NCT02949141
Last Updated: 2017-09-19
Results Overview
Sensitivity and specificity of ultrasound compared to chest x-ray for the diagnosis of pneumonia using Chest CT as the gold standard for diagnosis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
9 months
Results posted on
2017-09-19
Participant Flow
All patients eligible for the study were included and received all three imaging modalities.
Participant milestones
| Measure |
All Participants
All patients will initially get an ultrasound (interpreted by emergency department physician) followed by chest x-ray (read by independent radiologist) and computed tomography (read by radiologist)
Lung Ultrasound: All patients will receive lung ultrasound, chest x-ray and computed tomography.
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ultrasound
n=62 Participants
All patients will initially get an ultrasound (interpreted by emergency department physician) followed by chest x-ray (read by independent radiologist) and computed tomography (read by radiologist)
Lung Ultrasound: All patients will receive lung ultrasound, chest x-ray and computed tomography.
No adverse events were recorded.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=62 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=62 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=62 Participants
|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 14.5 • n=62 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=62 Participants
|
|
Region of Enrollment
Nepal
|
62 participants
n=62 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: 62
Sensitivity and specificity of ultrasound compared to chest x-ray for the diagnosis of pneumonia using Chest CT as the gold standard for diagnosis.
Outcome measures
| Measure |
Ultrasound
n=62 Participants
Ultrasound Diagnosis of pneumonia compared to CT (Gold Standard)
|
Chest X-Ray
n=62 Participants
Chest x-ray diagnosis of pneumonia compared to CT
|
|---|---|---|
|
Diagnosis of Pneumonia
US (or CXR) and CT positive pneumonia
|
40 Participants
|
32 Participants
|
|
Diagnosis of Pneumonia
US (or CXR) negative, CT positive
|
4 Participants
|
12 Participants
|
|
Diagnosis of Pneumonia
US (or CXR) positive, CT negative
|
7 Participants
|
9 Participants
|
|
Diagnosis of Pneumonia
US (or CXR) negative, CT negative
|
11 Participants
|
9 Participants
|
Adverse Events
Ultrasound
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chest X-ray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chest Ct
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place