Respiratory Intensive Care Unit Patients With Ventilator Associated PneumoniaNCT06090032
Compined SONOPULMONARY Infection Score and APACHE Score in RICU Patients With VAP
An observational study of Respiratory Intensive Care Unit Patients With Ventilator Associated Pneumonia, run by Assiut University.
Trial summary
Aim of the study : 1. Efficacy of Sono pulmonary infection score in combination with APACHE score in early diagnosis of VAP 2. Assessment of prediction role of combined SIPS SCORE and APACHE SCORE of outcome of VAP patient in RICU 3. Assessments of role of ultrasonography in early diagnosis and follow up of VAP Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Intensive Care Unit Patients With Ventilator Associated Pneumonia
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Dec 2024
- 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
- Adult, Older adult
Study population: Mechanically ventilated patients after first 48 hours of admission in RICU .
Who may be able to join
- Age >18 yrs
- Mechanically ventilated patients after first 48 hours of admission in RICU
Who cannot join
- Age <18 yrs
- Patients already diagnosed pneumonia
- Malignancy
- patient refused participation in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Copmined Sono-pulmonary Score and APACHE Score as a Predictor of Outcome in Respiratory Intensive Care Unit Patients With Ventilator Associated Pneumonia
Aim of the study :
- Efficacy of Sono pulmonary infection score in combination with APACHE score in early diagnosis of VAP
- Assessment of prediction role of combined SIPS SCORE and APACHE SCORE of outcome of VAP patient in RICU
- Assessments of role of ultrasonography in early diagnosis and follow up of VAP
Read the detailed description
Pneumonia is a bacterial, viral or fungal infection of the lungs, which causes the alveoli of the lungs to fill up with microorganisms, fluid and inflammatory cells, preventing the lungs from functioning effectively[1]. Ventilator associated pneumonia (VAP) is the most common and a leading cause of death in intensive care unit patient. Ventilator associated pneumonia is caused by prolonged duration of mechanical ventilation ,and prolonged hospital stay, which increase hospital costs, possibly increase mortality rate, and increase antibiotic use in ICU patients , early identification of VAP is an important clinical goal to improve patient outcomes [2]. In recent year several scoring systems have been developed to evaluate the severity of illness and to predict the outcome, especially the mortality rate of intensive care unit patient, such as the Clinical pulmonary infection score (CPIS) or modified (CPIS)The Clinical Pulmonary Infection Score (CPIS) was developed to serves a tool to facilitate the diagnosis of ventilator-associated pneumonia (VAP),The CPIS is calculated on the basis of points assigned for various signs and symptoms of pneumonia (eg, fever and extent of oxygenation mpairment) ,a CPIS has an average between 0-12>6 some studies suggest that CPIS >6 may correlate with VAP Sonar is easy bedside test to diagnose pleural effusion, pneumonia pneumothorax , so recently lung ultrasonography (LUS) incorporated in evaluation and diagnosis of VAP in a new score called sono pulmonary infection score (SPIS) . The (SPIS), where is incorporated LUS finding instead of CXR finding of CPIS is assigned two points for ≥ one area of dynamic air bronchogram. One point was given for ≥ two sub-pleural consolidation or lobar consolidation areas or ≥ one sub-pleural, and ≥one lobar consolidationRecently (combination of SPIS with APACHE score in assessment of VAP is under research ).
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
We will use ultrasongraphy as a part of assessment in respiratory intensive care unit patients with ventilator associated pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Compined SONOPULMONARY infection score and APACHE score as a predictor of outcome in RICU patients with ventilator associated pneumonia
Compined SONOPULMONARY infection score and APACHE score as a predictor of outcome of respiratory intensive care unit patients with ventilator associated pneumonia
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Intensive Care Unit Patients With 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Hussein Fouda, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090032
- Sponsor's protocol ID
- Chest U/S in RICU PT WITH VAP
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copmined Sono-pulmonary Score and APACHE Score as a Predictor of Outcome in Respiratory Intensive Care Unit Patients With Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT06090032
- Acronym / sponsor ID
- Chest U/S in RICU PT WITH VAP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 19 Oct 2023 (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.
Aim of the study :
- Efficacy of Sono pulmonary infection score in combination with APACHE score in early diagnosis of VAP
- Assessment of prediction role of combined SIPS SCORE and APACHE SCORE of outcome of VAP patient in RICU
- Assessments of role of ultrasonography in early diagnosis and follow up of VAP
Detailed description
Pneumonia is a bacterial, viral or fungal infection of the lungs, which causes the alveoli of the lungs to fill up with microorganisms, fluid and inflammatory cells, preventing the lungs from functioning effectively[1]. Ventilator associated pneumonia (VAP) is the most common and a leading cause of death in intensive care unit patient. Ventilator associated pneumonia is caused by prolonged duration of mechanical ventilation ,and prolonged hospital stay, which increase hospital costs, possibly increase mortality rate, and increase antibiotic use in ICU patients , early identification of VAP is an important clinical goal to improve patient outcomes [2]. In recent year several scoring systems have been developed to evaluate the severity of illness and to predict the outcome, especially the mortality rate of intensive care unit patient, such as the Clinical pulmonary infection score (CPIS) or modified (CPIS)The Clinical Pulmonary Infection Score (CPIS) was developed to serves a tool to facilitate the diagnosis of ventilator-associated pneumonia (VAP),The CPIS is calculated on the basis of points assigned for various signs and symptoms of pneumonia (eg, fever and extent of oxygenation mpairment) ,a CPIS has an average between 0-12>6 some studies suggest that CPIS >6 may correlate with VAP Sonar is easy bedside test to diagnose pleural effusion, pneumonia pneumothorax , so recently lung ultrasonography (LUS) incorporated in evaluation and diagnosis of VAP in a new score called sono pulmonary infection score (SPIS) . The (SPIS), where is incorporated LUS finding instead of CXR finding of CPIS is assigned two points for ≥ one area of dynamic air bronchogram. One point was given for ≥ two sub-pleural consolidation or lobar consolidation areas or ≥ one sub-pleural, and ≥one lobar consolidationRecently (combination of SPIS with APACHE score in assessment of VAP is under research ).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients after first 48 hours of admission in RICU .
Key inclusion criteria (2 listed)
- Age >18 yrs
- Mechanically ventilated patients after first 48 hours of admission in RICU
Key exclusion criteria (4 listed)
- Age <18 yrs
- Patients already diagnosed pneumonia
- Malignancy
- patient refused participation in the study.
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 |
|---|---|---|
| UltrasoundWe will use ultrasongraphy as a part of assessment in respiratory intensive care unit patients with ventilator associated pneumonia | Device | – |
Primary outcome
Compined SONOPULMONARY infection score and APACHE score as a predictor of outcome in RICU patients with ventilator associated pneumonia
Time frame: One year
Compined SONOPULMONARY infection score and APACHE score as a predictor of outcome of respiratory intensive care unit patients with ventilator associated pneumonia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- The National Institute for Health and Care Excellence (NICE), Pneumonia in adults: diagnosis and management. 2019Link provided by the sponsor.
- 3\. (Klevens RM, Edwards JR, Richards CL, et al. Estimating health careassociated infections and deaths in U.S. hospitals, 2002, Public Health Rep, 2007, vol. 122 (pg. 160-166).Link provided by the sponsor.
- 4\. Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A et al. Lung ultrasound for early diagnosis of ventilator-associated pneumonia. Chest. 2016;;149((4):969--980.. doi: 10.1016/j.chest.2015.12.012Link provided by the sponsor.
- . Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: A physiologically based classification system. Crit Care Med. 1981;9:591-7.Link provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Intensive Care Unit Patients With Ventilator Associated Pneumonia, 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 2 inclusion and 4 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 19 Oct 2023. 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?
Contact Lamiaa hussein Fouda, Master (01140705774, Lamiaahussein5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compined SONOPULMONARY infection score and APACHE score as a predictor of outcome in RICU patients with ventilator associated pneumonia (time frame: One year). 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 19 Oct 2023.