Clinical profile of acute respiratory distress syndrome in patients admitted to Acharya Vinoba Bhave Rural Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 3.Duration of mechanical ventilation
研究概览
简要总结
Introduction
Acute respiratorydistress syndrome (ARDS) is a lung injury causing significant morbidity andmortality in critically ill patients. The cause can be directly or indirectlycaused by factors such as pneumonia, toxic gas inhalation, sepsis, or trauma.The etiology of ARDS may differ in India due to higher incidence of tropicalinfectious diseases. Early diagnosis can be made by physicians with a highindex of suspicion and a thorough understanding of the disease’s naturalhistory. Careful assessment of oxygenation, ventilation, and acid base statuscan help determine the need for intervention. The syndrome can be triggered byvarious factors, including pulmonary or extrapulmonary sepsis, aspiration,trauma, blood product transfusion, or pancreatitis. Non-invasive ventilation(NIV) in ARDS is contentious, with no large definitive studies. Propertreatment of precipitating infections is crucial for survival.
The BerlinDefinition is a set of diagnostic criteria for Acute Respiratory DistressSyndrome (ARDS) that was proposed in 2012 as an update to the olderAmerican-European Consensus Conference (AECC) criteria. The Berlin Definitionaimed to provide more specific and standardized criteria for the diagnosis ofARDS. Here are the key components of the Berlin criteria for ARDS:
Timing:
ARDS symptoms startwithin a week of a known problem or worsening breathing.
Chest Imaging:
X-ray or CT scan showscloudy areas in both lungs.
Cause of BreathingTrouble:
Breathing trouble isnot solely due to heart issues or too much fluid.
Oxygen Levels:
Oxygen levels in theblood are measured by the PaO2/FiO2 ratio.
ARDS isclassified as mild, moderate, or severe based on this ratio.
Aims and objectives
Aims:
To study clinicalprofile of ARDS.
Objectives
1.To study etiologicaland clinical profile of ARDS.
2.To study clinicalcharacteristics , diagnostics and therapeutic modalities in ARDS.
3.To study outcome inpatients of ARDS.
Materials andMethods
STUDY DESIGN-PROSPECTIVE OBSERVATIONAL
STUDYDURATION: JANUARY 2024-DECEMBER 2025
STUDY POPULATION : PATIENT WITH ARDS IN AVBRH
INCLUSIONCRITERIA
1.Patients fulfillingberlin’s definition of ARDS
EXCLUSIONCRITERIA
1.Patients with age<18years
2.Patients or ptrelatives not willing to give consent
- Patients with heartfailure
INVESTIGATIONS:
Complete Blood Count,Lipid profile, Thyroid profile, Blood sugar levels, Kidney and liver functiontests, Urine routine and microscopy, Chest xray, Ecg, 2D Echo, HRCT Thorax
Clinical assessment
Blood Pressure (BP),Pulse Rate (PR), Respiratory Rate (RR), Saturation, Temperature
Medical historydocumentation (Hypertension, Diabetes Mellitus, chronic illnesses,smoking/alcohol history)
StatisticalAnalysis
Continuousvariables: Expressed as Mean ‡ Standard Deviation, compared using unpairedt-test or ANOVA.
Categoricalvariables: Expressed as frequencies and percentages, analyzed using chi-squaretests.
Correlation analysis:Performed using Pearson’s or Spearman’s correlation coefficients.
Statistical software:SPSS version 27.0
Significance level: p< 0.05 considered statistically significant.
EthicalConsiderations
Informed Consent:Patients will be informed about study procedures in their native language.Written consent will be obtained.
Confidentiality:Patient data will be anonymized and stored securely in a password-protecteddatabase.
Adherence toGuidelines: The study follows institutional ethical committee guidelines andGood Clinical Practice (GCP) standards.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients fulfilling Berlins criteria.
排除标准
- •1.Patients age less than 18 years 2.patients or patient relatives not willing to give consent 3.patients with heart failure.
结局指标
主要结局
3.Duration of mechanical ventilation
时间窗: 1.Until hospital discharge | 2.Until extubation | 3.Discharge from ICU
2.ICU length of stay
时间窗: 1.Until hospital discharge | 2.Until extubation | 3.Discharge from ICU
1.Mortality rate
时间窗: 1.Until hospital discharge | 2.Until extubation | 3.Discharge from ICU
次要结局
- 1.Oxygenation Improvement (PaO2/FiO2 Ratio)(2.Organ Dysfunction)
