A observational study of symptoms and patterns of Acute Respiratory Distress Syndrome

Not yet recruiting

Conditions: Diseases of the respiratory system,

Registration Number: CTRI/2025/06/088191

Lead Sponsor: Datta Meghe Institute of Higher Education and Research

Brief Summary: **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

3. 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients fulfilling Berlins criteria.

Exclusion Criteria

1.Patients age less than 18 years 2.patients or patient relatives not willing to give consent 3.patients with heart failure.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.ICU length of stay	1.Until hospital discharge \| 2.Until extubation \| 3.Discharge from ICU
3.Duration of mechanical ventilation	1.Until hospital discharge \| 2.Until extubation \| 3.Discharge from ICU
1.Mortality rate	1.Until hospital discharge \| 2.Until extubation \| 3.Discharge from ICU

Secondary Outcome Measures

Name	Time	Method
1.Oxygenation Improvement (PaO2/FiO2 Ratio)	2.Organ Dysfunction

Trial Locations

Locations (1): Datta Meghe Institution of Higher Education and Research
🇮🇳
Wardha, MAHARASHTRA, India
Datta Meghe Institution of Higher Education and Research
🇮🇳Wardha, MAHARASHTRA, India
Dr Mummaneni Rashmika
Principal investigator
09494957969
rashmika.m4u@gmail.com