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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07269743
Acronym
AERO-IN-ARDS
Enrollment
423
Registered
2025-12-08
Start date
2025-12-10
Completion date
2026-12-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS (Acute Respiratory Distress Syndrome) Receiving IMV

Keywords

ARDS, AEROSOL THERAPY, INVASIVE MECHANICAL VENTILATION

Brief 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.

Detailed description

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.

Interventions

DRUGTypes 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

All India Institute of Medical Sciences
CollaboratorOTHER
All India Institute of Medical Sciences, Raipur
CollaboratorOTHER_GOV
Ram Manohar Lohia Institute of Medical Sciences, Lucknow
CollaboratorUNKNOWN
Sanjay Gandhi Postgraduate Institute of Medical Sciences
CollaboratorOTHER_GOV
Hospital General Universitario Morales Meseguer
CollaboratorOTHER
Istanbul Medipol University Hospital
CollaboratorOTHER
Casa di Cura del Policlinico di Milano
CollaboratorUNKNOWN
HOSPITAL BRITANICO DE BUENOS AIRES
CollaboratorOTHER
TS Misra Medical College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
FREQUENCY OF AEROSOL THERAPY6 MONTHSHOW MANY ARDS PATIENTS WERE RECEIVING AEROSOL THERAPY
TYPES OF drug USED as aerosol therapy6 MONTHSHOW MANY TYPES OF DRUGS WERE USED AS AEROSOL THERAPY IN ARDS PATIENTS
frequency of aerosol therapy6 MONTHSFREQUENCY OF AEROSOL THERAPY IN ARDS PATIENTS ON IMV
types of drugs use as aerosol therapy6 monthstypes of drugs use as aerosol therapy in ARDS patients while receiving Invasive Mechanical Ventilation

Secondary

MeasureTime frameDescription
Modality used for aerosol drug delivery6 MONTHSTYPES OF AEROSOL GENERATORS USED TO DELIVER AEROSOL THERAPY IN ARDS PATIENTS
Types of aerosol generators used for aerosol drug delivery6 monthsTypes of aerosol generators used for aerosol drug delivery in ARDS patients while receiving IMV

Countries

India

Contacts

Primary ContactPiyush srivastava, MD
drpiyush16@yahoo.co.in+91-9415107512
Backup ContactSanjay Singhal, MD, EDRM, FCCP, PGDAST
drsanjaysinghal79@yahoo.co.in+91-9198991155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026