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

NCT07269743 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 423

Last updated 2025-12-15

No results posted yet for this 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.

Conditions

  • ARDS (Acute Respiratory Distress Syndrome) Receiving IMV

Interventions

DRUG

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.

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    collaborator OTHER
  • All India Institute of Medical Sciences, Raipur

    collaborator OTHER_GOV
  • Ram Manohar Lohia Institute of Medical Sciences, Lucknow

    collaborator UNKNOWN
  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    collaborator OTHER_GOV
  • Hospital General Universitario Morales Meseguer

    collaborator OTHER
  • Istanbul Medipol University Hospital

    collaborator OTHER
  • Casa di Cura del Policlinico di Milano

    collaborator UNKNOWN
  • HOSPITAL BRITANICO DE BUENOS AIRES

    collaborator OTHER
  • TS Misra Medical College

    lead OTHER

Principal Investigators

  • Mohan Gurjjar, MD · SGPGIMS

  • Berkan Basancelebi, RT, PT, MSc, FNIV · Medipol University

  • Gustavo Plotnikow, BPT, BCs, PhD(c) · Servicio de Rehabilitación, área de Kinesiología UCI, Hospital Británico de Buenos Aires, Buenos Aires, Argentina Facultad de Medicina Y Ciencias de la Salud, Universidad Abierta lnteramericana, Buenos Aires, Argentina

  • Giuseppe Francesco Sferrazza Papa, MD PhD · Casa di cura policlinico, department of rehabilitation sciences, Milan, (Italy)

  • Salvatore Notaro, MD · AORN colli Hospitals

  • Antonio M Esquinas, MD, PhD, FCCP, FNIV, FBCV · Instituto Murciano de Investigacion Biosanitaria, Murcia, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2026-12-01
Completion
2026-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269743 on ClinicalTrials.gov