PneumoniaNCT00118651
Clinical Indicators of Radiographic Findings in Patients With Suspected Community-Acquired Pneumonia
An observational study of Pneumonia, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial summary
This is a study involving the emergency department and outpatient clinics of the David Grant United States Air Force (USAF) Medical Center, a tertiary care facility. Patients 18 years of age or older with acute respiratory symptoms and positive or equivocal chest radiographs from October 1, 2004 through May 31, 2005… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Apr 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adult patients (18 years of age or older) with acute respiratory symptoms and positive chest radiographs from October 2004 through April 2005 were enrolled as positive cases with an equal number of controls with acute respiratory symptoms but negative radiographs; controls were matched by age and date of radiograph
Who may be able to join
- 18 years of age or older
- acute respiratory symptoms
- positive chest radiographs
- patients from outpatient clinics and the emergency department
Who cannot join
- under the age of 18
- suspected hospital-acquired pneumonia (positive radiographs within 10 days of hospital discharge)
- suspected aspiration pneumonia
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant USAF Medical Center
Travis Air Force Base, California, 94535
About this study
Official title: Clinical Indicators of Radiographic Findings in Patients With Suspected Community-Acquired Pneumonia: Who Needs a Chest X-Ray?
This is a study involving the emergency department and outpatient clinics of the David Grant United States Air Force (USAF) Medical Center, a tertiary care facility. Patients 18 years of age or older with acute respiratory symptoms and positive or equivocal chest radiographs from October 1, 2004 through May 31, 2005 will be included as positive cases. Controls will be randomly selected from a review of negative chest radiograph reports with a clinical history of an acute respiratory illness over the same time period. Once patients are appropriately identified as control or cases, outpatient charts will be reviewed to gather data on six clinical indicators. Sensitivities and specificities will be calculated for each clinical indicator, to determine which patients require chest radiographs in the setting of suspected community acquired pneumonia (CAP)
Read the detailed description
This was a retrospective study designed to evaluate the efficacy of six clinical indicators to predict the presence of pulmonary infiltrates on chest radiography.
The study population will include a convenience sample of David Grant Air Force Medical Center patients that meet study criteria. Adult patients (18 years of age or older) with acute respiratory symptoms and positive chest radiographs from October 2004 through April 2005 will be enrolled as positive cases. There will be an equal number of controls with acute respiratory symptoms but negative radiographs. Controls will be matched by age and date of radiograph. Patients/Cases with suspected hospital-acquired (positive radiographs within 10 days of hospital discharge) or aspiration pneumonia will be excluded
Six clinical indicators were selected based on the cumulative results of seminal studies that included: cough, sputum production, temperature, heart rate, respiratory rate, and findings on physical examination. Abnormal vital signs were defined as temperature of 100.5 degrees Fahrenheit (38 degrees Celsius) or greater, heart rate greater than or equal to 100 beats per minute, and respiratory rate greater than 20 breaths per minute. Positive physical examination findings consisted of the presence of crackles, decreased breath sounds, dullness to percussion, egophony, or rhonchi
Outpatient emergency room physicians will record data regarding the clinical indicators prior to obtaining chest radiographs; thus, they will be blinded to the radiographic findings. All chests radiographs will be subsequently interpreted by a board-certified radiologist blinded to the clinical findings. Positive radiographic findings will be defined as the presence of a new air space opacities in the setting of acute respiratory symptoms. Patients with equivocal radiographic findings interpreted as "possible pneumonia" will be considered positive cases. For each positive case, a single control was randomly selected from a list of eligible controls with acute respiratory symptoms, negative chest radiographs, and a date of birth within five years of that of the positive case.
Once patients are appropriately identified as cases or controls, outpatient charts will be reviewed to gather data regarding the six clinical indicators will be entered into the study database for analysis upon completion of the study. The sample size necessary to predict the proportion of patients with CAP who have all six clinical indicators was calculated as 385, assuming 95% confidence level and a 5% margin of error. Sample size estimates assume a random sample, which is not possible for us to obtain in this study; any conclusion that we draw will thus e cautiously interpreted. We will conduct this study for a minimum of one year with the intent to continue until a sample size of at least 385 is obtained. Upon completion of the study sensitivities and specificities and accompanying 95% confidence intervals for clinical indicators will be made to determine which combination of indicators best predicts the presence of pulmonary infiltrates in patients with CAP. Further analysis will be made within specific age groups (e.g., 18-40, 41-60, older than 60) and amongst those patients with pre-existing pulmonary disease
- Conditions
- Pneumonia
- Keywords
- pneumonia, chest x-ray, respiratory infection, prediction rule, thoracic imaging
- Medical subject headings
- Pneumonia, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Positive cases | Positive radiographic findings were defined as the presence of a new air space opacities in the setting of acute respiratory symptoms. Patients with equivocal radiographic findings interpreted as "possible pneumonia" were considered positive cases | |
| Control | Acute respiratory symptoms, negative chest radiographs, and a date of birth within five years of that of the positive case |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startOct 2004
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William T. O'Brien, D.O., Principal investigator, David Grant USAF Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118651
- Sponsor's protocol ID
- FDG20040023H
- Status last verified
- Apr 2020
- First submitted
- 1 Jul 2005
- Last updated
- 17 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Indicators of Radiographic Findings in Patients With Suspected Community-Acquired Pneumonia: Who Needs a Chest X-Ray?
- ClinicalTrials.gov ID
- NCT00118651
- Acronym / sponsor ID
- FDG20040023H
- Conditions
- Pneumonia
- Keywords
- pneumonia, chest x-ray, respiratory infection, prediction rule, thoracic imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- Oct 2004 (actual)
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 12 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study involving the emergency department and outpatient clinics of the David Grant United States Air Force (USAF) Medical Center, a tertiary care facility. Patients 18 years of age or older with acute respiratory symptoms and positive or equivocal chest radiographs from October 1, 2004 through May 31, 2005 will be included as positive cases. Controls will be randomly selected from a review of negative chest radiograph reports with a clinical history of an acute respiratory illness over the same time period. Once patients are appropriately identified as control or cases, outpatient charts will be reviewed to gather data on six clinical indicators. Sensitivities and specificities will be calculated for each clinical indicator, to determine which patients require chest radiographs in the setting of suspected community acquired pneumonia (CAP)
Detailed description
This was a retrospective study designed to evaluate the efficacy of six clinical indicators to predict the presence of pulmonary infiltrates on chest radiography.
The study population will include a convenience sample of David Grant Air Force Medical Center patients that meet study criteria. Adult patients (18 years of age or older) with acute respiratory symptoms and positive chest radiographs from October 2004 through April 2005 will be enrolled as positive cases. There will be an equal number of controls with acute respiratory symptoms but negative radiographs. Controls will be matched by age and date of radiograph. Patients/Cases with suspected hospital-acquired (positive radiographs within 10 days of hospital discharge) or aspiration pneumonia will be excluded
Six clinical indicators were selected based on the cumulative results of seminal studies that included: cough, sputum production, temperature, heart rate, respiratory rate, and findings on physical examination. Abnormal vital signs were defined as temperature of 100.5 degrees Fahrenheit (38 degrees Celsius) or greater, heart rate greater than or equal to 100 beats per minute, and respiratory rate greater than 20 breaths per minute. Positive physical examination findings consisted of the presence of crackles, decreased breath sounds, dullness to percussion, egophony, or rhonchi
Outpatient emergency room physicians will record data regarding the clinical indicators prior to obtaining chest radiographs; thus, they will be blinded to the radiographic findings. All chests radiographs will be subsequently interpreted by a board-certified radiologist blinded to the clinical findings. Positive radiographic findings will be defined as the presence of a new air space opacities in the setting of acute respiratory symptoms. Patients with equivocal radiographic findings interpreted as "possible pneumonia" will be considered positive cases. For each positive case, a single control was randomly selected from a list of eligible controls with acute respiratory symptoms, negative chest radiographs, and a date of birth within five years of that of the positive case.
Once patients are appropriately identified as cases or controls, outpatient charts will be reviewed to gather data regarding the six clinical indicators will be entered into the study database for analysis upon completion of the study. The sample size necessary to predict the proportion of patients with CAP who have all six clinical indicators was calculated as 385, assuming 95% confidence level and a 5% margin of error. Sample size estimates assume a random sample, which is not possible for us to obtain in this study; any conclusion that we draw will thus e cautiously interpreted. We will conduct this study for a minimum of one year with the intent to continue until a sample size of at least 385 is obtained. Upon completion of the study sensitivities and specificities and accompanying 95% confidence intervals for clinical indicators will be made to determine which combination of indicators best predicts the presence of pulmonary infiltrates in patients with CAP. Further analysis will be made within specific age groups (e.g., 18-40, 41-60, older than 60) and amongst those patients with pre-existing pulmonary disease
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive cases | – | –Positive radiographic findings were defined as the presence of a new air space opacities in the setting of acute respiratory symptoms. Patients with equivocal radiographic findings interpreted as "possible pneumonia" were considered positive cases |
| Control | – | –Acute respiratory symptoms, negative chest radiographs, and a date of birth within five years of that of the positive case |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (18 years of age or older) with acute respiratory symptoms and positive chest radiographs from October 2004 through April 2005 were enrolled as positive cases with an equal number of controls with acute respiratory symptoms but negative radiographs; controls were matched by age and date of radiograph
Key inclusion criteria (4 listed)
- 18 years of age or older
- acute respiratory symptoms
- positive chest radiographs
- patients from outpatient clinics and the emergency department
Key exclusion criteria (3 listed)
- under the age of 18
- suspected hospital-acquired pneumonia (positive radiographs within 10 days of hospital discharge)
- suspected aspiration pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William T. O'Brien, D.O. principal investigator
David Grant USAF Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.