ARDS (Acute Respiratory Distress Syndrome)
Conditions
Keywords
ARDS, Salivary biomarkers, IL-6, TNF alfa, BAL biomarkers
Brief summary
The aim of this study is to determine the degree of agreement in cytokines level measured through BAL and those measured through salivary glands excretion. and to compare the validity of cytokines in BAL versus salivary secretion in predicting the stage of ARDS and disease outcome in term of mortality, disease progression and length of stay.
Detailed description
• BAL will be performed by the attending pediatric intensivist in pediatric intensive care unit as part of standard care for ARDS management and Saliva samples will be collected non-invasively using sterile collection devices IL6 and TNF alfa will measured in both samples and compared to each other
Interventions
DIAGNOSTIC_TESTBronchoscopy
Comparison between levels of inflammatory markers in both BAL \&salivary secretions
Sponsors
Ain Shams University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Pediatric Acute Respiratory Distress Syndrome (ARDS) * Age range: 1 month to 18 years * Requirement for invasive mechanical ventilation * Availability of salivary and bronchoalveolar lavage (BAL) samples within 24 hours of ARDS diagnosis * Informed consent obtained from parent or legal guardian
Exclusion criteria
* Pre-existing chronic lung disease (e.g., cystic fibrosis, bronchopulmonary dysplasia) * Known immunodeficiency or current immunosuppressive therapy * Active malignancy or receipt of chemotherapy within the past 6 months * Severe congenital anomalies incompatible with survival * Refusal or inability to obtain informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between BAL and salivary cytokine levels | Within 24 hours of ARDS diagnosis | Degree of agreement between cytokine concentrations measured in bronchoalveolar lavage (BAL) fluid and salivary gland secretions collected simultaneously, assessed using intraclass correlation coefficients and Bland-Altman analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of ARDS severity by cytokine levels | First 48-72 hours | Ability of BAL and salivary cytokine levels to predict ARDS severity according to established criteria. |
| Association of cytokine levels with in-hospital mortality | Through the study completion ( anaverage one year) | Relationship between cytokine concentrations and all-cause in-hospital mortality. |
| Association of cytokine levels with disease progression | Through the study completion of average one year | Relationship between cytokine levels and worsening ARDS severity or escalation of respiratory support. |
| Association of cytokine levels with length of hospital stay | Through the study completion ( an average one year) | Relationship between cytokine concentrations and length of hospital stay. |
| Comparative predictive performance of BAL versus salivary cytokines | Through a study completion of average one year | Comparison of BAL and salivary cytokines in predicting ARDS severity, mortality, disease progression, and length of stay. |
Countries
Egypt
Contacts
STUDY_DIRECTORDr. Tarekahmed Abdelgawad
Ain Shams University
Outcome results
None listed