Performance of Novel Bed Side Scores as Predictors of Hospital Outcome in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Among Women; Cohort Study

Study Overview
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Brief Summary
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Assess predictors of mortality in COPD exacerbation between men and women. Evaluate the clinical outcomes in acute exacerbation of COPD in women. Evaluate the validity of new scoring systems ( NIVO, DECAF, HACOR ) as a predictor for hospital outcome in acute exacerbation of COPD. Compare these new scoring system with the most widely used APACHE IV. Assessment of serum level of granulocyte colony stimulating factor ( GM-CSF) in detecting the severity of COPD exacerbation.

Official Title
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Performance of Novel Bed Side Scores as Predictors of Hospital Outcome in Acute Exacerbation of Chronic Obstructive Pulmonary Disease Among Women; Cohort Study

Conditions
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COPD Exacerbation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with AECOPD leading to hypoxemia, hypercapnia and respiratory acidosis with pH < 7.35 and PaCO2 > 45 mm of Hg will be admitted to the respiratory intensive care unit (ICU) for NIV or the ward will be eligible for inclusion and not in need for mechanical ventilation Exclusion Criteria: Requirement for emergency intubation. Other contraindications to NIPPV including cardiac or respiratory arrest; nonrespiratory organ failure (eg, severe encephalopathy, severe gastrointestinal bleeding, hemodynamic instability with or without unstable cardiac angina); facial surgery or trauma; upper-airway obstruction; inability to protect the airway and/or high risk of aspiration; and inability to clear secretions.(6) Age < 35 years.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female COPD<br> | |
| Male COPD<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate among COPD patients hospitalized due to acute exacerbation. | Assessment of mortality with different scoring systems in acute exacerbation of COPD | 28 days from admissiom | 
| Early prediction of NIV failure. | Using NIVO score for Acute exacerbaion of COPD Non-invasive ventilation outcomes score is considered to be Low risk ( 0-2) Moderate risk (3-4) High risk (5-6) Very high risk ( 7-9) | 48 hours from ICU admission | 
| Assessment of GM-CSF as a biomarker for successful therapy in acute exacerbation of COPD. | Assessment of granulocyte colony stimulating factor by ELISA test in acute exacerbation of COPD | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assisted ventilation days. | Estimating the number of days required for either non-invasive or invasive mechanical ventilation | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIVO, DECAF, HACOR