To OBSERVE PRACTISE OF AEROSOL THERAPY IN ARDS PATIENTS (AERO-IN-ARDS)
| Registry | NCT07269743, acronym AERO-IN-ARDS |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 423 (Estimated) |
| Sponsor | TS Misra Medical College (Other); collaborators: All India Institute of Medical Sciences, All India Institute of Medical Sciences, Raipur, Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Hospital General Universitario Morales Meseguer, Istanbul Medipol University Hospital, Casa di Cura del Policlinico di Milano, HOSPITAL BRITANICO DE BUENOS AIRES |
| Conditions | ARDS (Acute Respiratory Distress Syndrome) Receiving IMV |
| Interventions | Types of drugs being delivered as aerosol therapy (Drug) |
| Dates | start 2025-12-10 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-31 (estimated), first posted 2025-12-08, last updated 2025-12-15 |
| Locations | 1 site in India |
Related Papers Related Patents Related Grants Related Experts
All trials for ARDS (Acute Respiratory Distress Syndrome) Receiving IMV All trials of Types of drugs being delivered as aerosol therapy
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.
This prospective, multi-center, international cohort observational study will be conducted upon approval from the Institutional Ethics Committee (IEC). Centers' recruitment from various parts of the Globe will be done on an invitation basis. Participation in centers will be purely voluntary. As per their local policy, the participating center will take additional IEC approval or waiver at their center to initiate enrollment. Requests for patients' or legal representatives' informed consent will be made in accordance with national law.
The study protocol is designed and will be reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. All consecutive eligible patients with ARDS admitted to participating ICUs will be enrolled. The study aims to include all consecutive eligible patients to ensure accurate and representative data collection. Each Participating center will screen all consecutive ARDS patients requiring invasive mechanical ventilation during the study's six-month inclusion period, or a maximum of 25 patients per center. Patients who met the inclusion/exclusion criteria will be followed for the next 14 days or till ICU discharge/death or weaning from IMV, whichever comes first.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ARDS PATIENTS | Drug: Types of drugs being delivered as aerosol therapy | REQUIREING INVASIVE MECHANICAL VENTILATION |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Ts Misra Medical College | Lucknow, Uttar Pradesh | India | Recruiting |