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临床试验/CTRI/2025/06/088191
CTRI/2025/06/088191尚未招募不适用

Clinical profile of acute respiratory distress syndrome in patients admitted to Acharya Vinoba Bhave Rural Hospital

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月16日最近更新:

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

  1. 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)

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college

研究点 (1)

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