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Clinical Trials in India / NCT07269743
Recruiting Observational

AEROSOL THERAPY IN ARDS PATIENTS (AERO-IN-ARDS)

NCT07269743 · tracked via the Priya Life Science India tracker
Sponsor
TS Misra Medical College
Phase
Observational
Started
2025-12-10
Last updated
2025-12-15

Condition(s) studied

ARDS (Acute Respiratory Distress Syndrome) Receiving IMV

Investigational drug(s) / intervention(s)

Types of drugs being delivered as aerosol therapy

Types of drugs being delivered as aerosol therapy: Every time the patient receives inhaled medication, except for the instillation of 0.9% normal saline in the artificial airway for suctioning, will be counted in aerosol therapy.

Study summary

Aerosol therapy delivers medicines as a fine mist directly into the lungs. This allows faster action and fewer whole-body side effects. It is a key treatment for diseases such as asthma and COPD. In acute respiratory distress syndrome (ARDS), early laboratory and small clinical studies suggested that inhaled beta-2 agonists and corticosteroids might help the lungs heal by improving mucus clearance, reducing inflammation, and helping remove excess fluid. However, larger randomized trials have not shown clear clinical benefits. Therefore, major guidelines do not provide specific recommendations for aerosol use in ARDS. There are also safety concerns, including risks of low potassium levels, abnormal heart rhythms, worsening lung function, and increased healthcare costs. Despite these uncertainties, our previous study showed that aerosol therapy continues to be used widely in ARDS patients. However, that study was small and limited to one country, so the findings may not apply to other regions.

To address this gap, we have designed Aero-in-ARDS, a large, multi-national, prospective observational study. This study will investigate how often aerosol therapy is used in ARDS, what types of aerosol drugs are given, and how practices differ across countries. By identifying current patterns and comparing them with existing evidence, the study aims to highlight gaps in knowledge and guide future research.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: all newly admitted adult patients with a diagnosis of ARDS in the participating ICU 1. The patient requires mechanical ventilation. 2. Age ≥ 18 years 3. Informed consent (if required) Exclusion Criteria: 1. Age \<18 years 2. Patients managed with NIV, and HFNO

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ts Misra Medical College Lucknow Uttar Pradesh Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07269743 on ClinicalTrials.gov ↗ ← All trials in India