Trial Outcomes & Findings for A Randomized Controlled Trial of Lung Ultrasound Compared to Chest X-ray for Diagnosing Pneumonia in the Emergency Department (NCT NCT01654887)
NCT ID: NCT01654887
Last Updated: 2017-03-10
Results Overview
The percentage of Participants For Whom CXR Was Not Needed (or received only lung US) to Diagnose Pneumonia. The primary objective of this study is to determine if it is possible for lung ultrasound (LUS) to replace chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, an overall reduction of CXR when LUS is used first. Null hypothesis is that LUS cannot replace CXR for the diagnosis of pneumonia. Alternate hypothesis is that LUS can replace CXR for pneumonia.
COMPLETED
NA
191 participants
up to 5 hours
2017-03-10
Participant Flow
Participants with suspected pneumonia in an emergency department were recruited from the Pediatric Emergency Department at Mount Sinai Hospital.
Participant milestones
| Measure |
Lung Ultrasound
Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
|
Chest X-Ray
Patients in the control arm underwent sequential imaging with CXR followed by LUS.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
88
|
|
Overall Study
COMPLETED
|
103
|
88
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Controlled Trial of Lung Ultrasound Compared to Chest X-ray for Diagnosing Pneumonia in the Emergency Department
Baseline characteristics by cohort
| Measure |
Lung Ultrasound
n=103 Participants
Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
|
Chest X-Ray
n=88 Participants
Patients in the control arm underwent sequential imaging with CXR followed by LUS.
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3 years
n=99 Participants
|
3 years
n=107 Participants
|
3 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Tachypnea for age
yes
|
27 participants
n=99 Participants
|
25 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Tachypnea for age
no
|
76 participants
n=99 Participants
|
63 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
Triage Fever >= 38 degrees celsius
yes
|
48 participants
n=99 Participants
|
41 participants
n=107 Participants
|
89 participants
n=206 Participants
|
|
Triage Fever >= 38 degrees celsius
no
|
55 participants
n=99 Participants
|
47 participants
n=107 Participants
|
102 participants
n=206 Participants
|
|
Cough
yes
|
101 participants
n=99 Participants
|
86 participants
n=107 Participants
|
187 participants
n=206 Participants
|
|
Cough
no
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Difficulty breathing
yes
|
56 participants
n=99 Participants
|
48 participants
n=107 Participants
|
104 participants
n=206 Participants
|
|
Difficulty breathing
no
|
47 participants
n=99 Participants
|
40 participants
n=107 Participants
|
87 participants
n=206 Participants
|
|
Chest pain
yes
|
17 participants
n=99 Participants
|
10 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Chest pain
no
|
86 participants
n=99 Participants
|
78 participants
n=107 Participants
|
164 participants
n=206 Participants
|
|
Abdominal pain
yes
|
12 participants
n=99 Participants
|
10 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Abdominal pain
no
|
91 participants
n=99 Participants
|
78 participants
n=107 Participants
|
169 participants
n=206 Participants
|
|
History of fever
yes
|
87 participants
n=99 Participants
|
75 participants
n=107 Participants
|
162 participants
n=206 Participants
|
|
History of fever
no
|
16 participants
n=99 Participants
|
13 participants
n=107 Participants
|
29 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 5 hoursThe percentage of Participants For Whom CXR Was Not Needed (or received only lung US) to Diagnose Pneumonia. The primary objective of this study is to determine if it is possible for lung ultrasound (LUS) to replace chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, an overall reduction of CXR when LUS is used first. Null hypothesis is that LUS cannot replace CXR for the diagnosis of pneumonia. Alternate hypothesis is that LUS can replace CXR for pneumonia.
Outcome measures
| Measure |
Lung Ultrasound
n=103 Participants
Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
|
Chest X-Ray
n=88 Participants
Patients in the control arm underwent sequential imaging with CXR followed by LUS.
|
|---|---|---|
|
Percentage of Participants For Whom CXR Was Not Needed to Diagnose Pneumonia
|
38.8 percentage of participants
Interval 30.0 to 48.9
|
0 percentage of participants
Interval 0.0 to 3.6
|
PRIMARY outcome
Timeframe: week 1-2Outcome measures
| Measure |
Lung Ultrasound
n=103 Participants
Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
|
Chest X-Ray
n=88 Participants
Patients in the control arm underwent sequential imaging with CXR followed by LUS.
|
|---|---|---|
|
Percentage of Participants Whose Pneumonia Was Missed by LUS or CXR
|
0.0 percentage of participants
Interval 0.0 to 2.9
|
0.0 percentage of participants
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: week 1-2Percentage of participants who had unscheduled healthcare visits after the index Emergency Department visit between those subjects who undergo CXR first and those who undergo LUS first.
Outcome measures
| Measure |
Lung Ultrasound
n=103 Participants
Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
|
Chest X-Ray
n=88 Participants
Patients in the control arm underwent sequential imaging with CXR followed by LUS.
|
|---|---|---|
|
Comparison of Unscheduled Healthcare Visits
|
8.7 percentage of participants
Interval 3.3 to 14.1
|
11.4 percentage of participants
Interval 4.8 to 18.0
|
SECONDARY outcome
Timeframe: weeks 1-2A chart review and follow up phone call made at 1-2 weeks to assess whether or not the subject was started on antibiotics during the index Emergency Department (ED) visit or at a later healthcare visit.
Outcome measures
| Measure |
Lung Ultrasound
n=103 Participants
Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
|
Chest X-Ray
n=88 Participants
Patients in the control arm underwent sequential imaging with CXR followed by LUS.
|
|---|---|---|
|
Percentage of Participants With Antibiotic Use
|
37.9 percentage of participants
Interval 28.5 to 47.2
|
27.3 percentage of participants
Interval 17.9 to 36.6
|
SECONDARY outcome
Timeframe: weeks 1-2Chart review and follow up phone call made at 1-2 weeks to assess whether or not the subject was admitted during the index ED visit or at a later healthcare visit.
Outcome measures
| Measure |
Lung Ultrasound
n=103 Participants
Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
|
Chest X-Ray
n=88 Participants
Patients in the control arm underwent sequential imaging with CXR followed by LUS.
|
|---|---|---|
|
Percentage of Participants Who Had Hospital Admission.
|
19.4 percentage of participants
Interval 11.8 to 27.0
|
17.0 percentage of participants
Interval 9.2 to 24.8
|
SECONDARY outcome
Timeframe: up to 5 hoursChart review conducted to assess overall LOS in the ED.
Outcome measures
| Measure |
Lung Ultrasound
n=103 Participants
Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
|
Chest X-Ray
n=88 Participants
Patients in the control arm underwent sequential imaging with CXR followed by LUS.
|
|---|---|---|
|
Comparison of the Length of Stay in the ED
|
153 minutes
Interval 120.0 to 252.0
|
180 minutes
Interval 139.0 to 241.0
|
Adverse Events
Lung Ultrasound
Chest X-Ray
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. James Tsung
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place