Ventilator Associated PneumoniaNCT04057625
Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia
A study testing transthoracic ultrasound in people with Ventilator Associated Pneumonia and Lung Ultrasound, run by Assiut University.
Trial summary
To evaluate the sensitivity, specificity and diagnostic accuracy of bedside transthoracic ultrasound examination in the diagnosis and follow up of ventilator associated pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Lung Ultrasound
- What is being tested?
- transthoracic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Oct 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation for at least 48 hours.
- New or evolving infiltrate on chest radiograph (CXR).
- Clinical pulmonary infection score more than or equal 6
Who cannot join
- Patients who are less than 18 years old.
- Patients who have evidence of pneumonia before or prior to being mechanically ventilated.
- Patients with pulmonary infarction.
About this study
To evaluate the sensitivity, specificity and diagnostic accuracy of bedside transthoracic ultrasound examination in the diagnosis and follow up of ventilator associated pneumonia.
Read the detailed description
VAP is the most frequent hospital-acquired infection in intensive care units. Depending on the diagnostic criteria used, its incidence ranges from 5% to 67%. The risk of acquiring VAP is 3% per day during the first 5 days on mechanical ventilation, and it is decreased to 1% per day for the following days.
VAP is suspected when subject shows high grade fever, increase in leukocyte count, change in color of sputum and tachypnea. It's a leading cause of mortality in 15- 65% of the cases.
Serial chest x-ray for diagnosis and follow up, done at time of diagnosis, after 5 days and after 10 days. Chest radiography is consistently carried out after LUS , LUS is done every other day, measuring the largest area of consolidation according to the intercostal space and direction of the probe . Chest radiography is read by two physicians.
- Conditions
- Ventilator Associated Pneumonia, Lung Ultrasound
- Being tested
- transthoracic ultrasound
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic ultrasoundDevice
using transthoracic ultrasound in the diagnosis and follow up of vap,measuring the largest area of consolidation according to intercostal space and the direction of the probe.
| Study group | Role | What they receive |
|---|---|---|
| lung ultrasound | Other | using lung ultrasound in diagnosis and follow up of vap measuring the largest area of consolidation according to intercostal space and the direction of the probe Receives: Device: transthoracic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
detecting ultrasound efficiency in diagnosis and follow up of vap
Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose and follow up ventilator-associated pneumonia.
Measured: baseline
Secondary outcomes (3)
icu stay
Duration of stay in ICU.
Measured: baseline
hospital stay
Duration of hospital stay.
Measured: basline
mortality
mortality from vap
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dina reda ragab gharieb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057625
- Sponsor's protocol ID
- sonar in vap
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT04057625
- Acronym / sponsor ID
- sonar in vap
- Conditions
- Ventilator Associated Pneumonia, Lung Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 15 Aug 2019 (actual)
- 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.
To evaluate the sensitivity, specificity and diagnostic accuracy of bedside transthoracic ultrasound examination in the diagnosis and follow up of ventilator associated pneumonia.
Detailed description
VAP is the most frequent hospital-acquired infection in intensive care units. Depending on the diagnostic criteria used, its incidence ranges from 5% to 67%. The risk of acquiring VAP is 3% per day during the first 5 days on mechanical ventilation, and it is decreased to 1% per day for the following days.
VAP is suspected when subject shows high grade fever, increase in leukocyte count, change in color of sputum and tachypnea. It's a leading cause of mortality in 15- 65% of the cases.
Serial chest x-ray for diagnosis and follow up, done at time of diagnosis, after 5 days and after 10 days. Chest radiography is consistently carried out after LUS , LUS is done every other day, measuring the largest area of consolidation according to the intercostal space and direction of the probe . Chest radiography is read by two physicians.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung ultrasound | Other | Device: transthoracic ultrasoundusing lung ultrasound in diagnosis and follow up of vap measuring the largest area of consolidation according to intercostal space and the direction of the probe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanical ventilation for at least 48 hours.
- New or evolving infiltrate on chest radiograph (CXR).
- Clinical pulmonary infection score more than or equal 6
Key exclusion criteria (3 listed)
- Patients who are less than 18 years old.
- Patients who have evidence of pneumonia before or prior to being mechanically ventilated.
- Patients with pulmonary infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transthoracic ultrasoundusing transthoracic ultrasound in the diagnosis and follow up of vap,measuring the largest area of consolidation according to intercostal space and the direction of the probe. | Device | lung ultrasound |
Primary outcome
detecting ultrasound efficiency in diagnosis and follow up of vap
Time frame: baseline
Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose and follow up ventilator-associated pneumonia.
3 secondary outcomes
icu stay
Time frame: baseline
hospital stay
Time frame: basline
mortality
Time frame: basline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transthoracic ultrasound in people with Ventilator Associated Pneumonia and Lung Ultrasound, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
What does the primary outcome measure?
detecting ultrasound efficiency in diagnosis and follow up of vap (time frame: baseline). It is what the study was designed to measure, not a finding.
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 26 Aug 2019.