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| Name | Class |
|---|---|
| All India Institute of Medical Sciences | OTHER |
| All India Institute of Medical Sciences, Raipur | OTHER_GOV |
| Ram Manohar Lohia Institute of Medical Sciences, Lucknow | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARDS PATIENTS | REQUIREING INVASIVE MECHANICAL VENTILATION |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| FREQUENCY OF AEROSOL THERAPY | HOW MANY ARDS PATIENTS WERE RECEIVING AEROSOL THERAPY | 6 MONTHS |
| TYPES OF drug USED as aerosol therapy | HOW MANY TYPES OF DRUGS WERE USED AS AEROSOL THERAPY IN ARDS PATIENTS | 6 MONTHS |
| frequency of aerosol therapy | FREQUENCY OF AEROSOL THERAPY IN ARDS PATIENTS ON IMV | 6 MONTHS |
| types of drugs use as aerosol therapy | types of drugs use as aerosol therapy in ARDS patients while receiving Invasive Mechanical Ventilation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modality used for aerosol drug delivery | TYPES OF AEROSOL GENERATORS USED TO DELIVER AEROSOL THERAPY IN ARDS PATIENTS | 6 MONTHS |
| Types of aerosol generators used for aerosol drug delivery | Types of aerosol generators used for aerosol drug delivery in ARDS patients while receiving IMV |
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Inclusion Criteria: all newly admitted adult patients with a diagnosis of ARDS in the participating ICU
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piyush srivastava, MD | Contact | +91-9415107512 | drpiyush16@yahoo.co.in | |
| Sanjay Singhal, MD, EDRM, FCCP, PGDAST | Contact | +91-9198991155 | drsanjaysinghal79@yahoo.co.in |
| Name | Affiliation | Role |
|---|---|---|
| Mohan Gurjjar, MD | SGPGIMS | Study Chair |
| Berkan Basancelebi, RT, PT, MSc, FNIV | Medipol University | Study Chair |
| Gustavo Plotnikow, BPT, BCs, PhD(c) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ts Misra Medical College | Recruiting | Lucknow | Uttar Pradesh | 226008 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41180103 | Background | Singhal S, Saran S, Joshi K, Gurjar M, Rao PB, Sahoo JN, Dua R, Sahoo AK, Sharma A, Agarwal S, Sharma A, Ghosh PS, Kothari N, Deokar K, Mukherjee S, Sharma P, Sreedevi B, Sivaramakrishnan P, Singh U, Sundaram D, Agrawal A. Practice pattern of aerosol drug therapy in ARDS patients: A secondary analysis of the Aero-in-ICU study. J Intensive Med. 2025 Jul 5;5(4):385-391. doi: 10.1016/j.jointm.2025.05.003. eCollection 2025 Oct. | |
| 38687231 |
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Access to STUDY IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.
6 months after publication of manuscript and the data will be made accessible for up to 24 months
qualified researchers engaging in independent scientific research
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| OTHER_GOV |
| Hospital General Universitario Morales Meseguer | OTHER |
| Istanbul Medipol University Hospital | OTHER |
| Casa di Cura del Policlinico di Milano | UNKNOWN |
| HOSPITAL BRITANICO DE BUENOS AIRES | OTHER |
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| 6 months |
| 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 |
| Study Chair |
| Giuseppe Francesco Sferrazza Papa, MD PhD | Casa di cura policlinico, department of rehabilitation sciences, Milan, (Italy) | Study Chair |
| Salvatore Notaro, MD | AORN colli Hospitals | Study Chair |
| Antonio M Esquinas, MD, PhD, FCCP, FNIV, FBCV | Instituto Murciano de Investigacion Biosanitaria, Murcia, Spain | Study Chair |
| Background |
| Singhal S, Gurjar M, Sahoo JN, Saran S, Dua R, Sahoo AK, Sharma A, Agarwal S, Sharma A, Ghosh PS, Rao PB, Kothari N, Joshi K, Deokar K, Mukherjee S, Sharma P, Sreedevi BP, Sivaramakrishnan P, Singh U, Sundaram D, Agrawal A, Katoch CDS. Aerosol drug therapy in critically ill patients (Aero-in-ICU study): A multicentre prospective observational cohort study. Lung India. 2024 May 1;41(3):200-208. doi: 10.4103/lungindia.lungindia_580_23. Epub 2024 Apr 30. |