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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

423 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-10

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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ARDS (Acute Respiratory Distress Syndrome) Receiving IMV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ARDS PATIENTS

REQUIREING INVASIVE MECHANICAL VENTILATION

Types of drugs being delivered as aerosol therapy

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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PIYUSH SRIVASTAVA

DR PIYUSH SRIVASTAVA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohan Gurjjar, MD

Role: STUDY_CHAIR

SGPGIMS

Berkan Basancelebi, RT, PT, MSc, FNIV

Role: STUDY_CHAIR

Medipol University

Gustavo Plotnikow, BPT, BCs, PhD(c)

Role: STUDY_CHAIR

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