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NCT Number: NCT07269743

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all newly admitted adult patients with a diagnosis of ARDS in the participating ICU

  • The patient requires mechanical ventilation.
  • Age ≥ 18 years
  • Informed consent (if required)

Exclusion criteria

  • Age <18 years
  • Patients managed with NIV, and HFNO

Treatment and study plan

Types of drugs being delivered as aerosol therapy

Drug

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.

Primary outcomes

  1. FREQUENCY OF AEROSOL THERAPY

    Time frame: 6 MONTHS

    HOW MANY ARDS PATIENTS WERE RECEIVING AEROSOL THERAPY

  2. TYPES OF drug USED as aerosol therapy

    Time frame: 6 MONTHS

    HOW MANY TYPES OF DRUGS WERE USED AS AEROSOL THERAPY IN ARDS PATIENTS

  3. frequency of aerosol therapy

    Time frame: 6 MONTHS

    FREQUENCY OF AEROSOL THERAPY IN ARDS PATIENTS ON IMV

  4. types of drugs use as aerosol therapy

    Time frame: 6 months

    types of drugs use as aerosol therapy in ARDS patients while receiving Invasive Mechanical Ventilation

Secondary outcomes

  1. Modality used for aerosol drug delivery

    Time frame: 6 MONTHS

    TYPES OF AEROSOL GENERATORS USED TO DELIVER AEROSOL THERAPY IN ARDS PATIENTS

  2. Types of aerosol generators used for aerosol drug delivery

    Time frame: 6 months

    Types of aerosol generators used for aerosol drug delivery in ARDS patients while receiving IMV

Study contacts

Contact information is provided by the study sponsor or research team.

Piyush srivastava, MD

CONTACT

[email protected]

+91-9415107512

Sanjay Singhal, MD, EDRM, FCCP, PGDAST

CONTACT

[email protected]

+91-9198991155

Sponsors and collaborators

Lead sponsor

TS Misra Medical College

Other

Collaborators

  • All India Institute of Medical Sciences
  • All India Institute of Medical Sciences, Raipur
  • Casa di Cura del Policlinico di Milano
  • HOSPITAL BRITANICO DE BUENOS AIRES
  • Hospital General Universitario Morales Meseguer
  • Istanbul Medipol University Hospital
  • Ram Manohar Lohia Institute of Medical Sciences, Lucknow
  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

Registry information

Official study title

To OBSERVE PRACTISE OF AEROSOL THERAPY IN ARDS PATIENTS (AERO-IN-ARDS)

Acronym: AERO-IN-ARDS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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