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

To OBSERVE PRACTISE OF 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.

Study Overview

• Status: Recruiting
• Conditions: ARDS (Acute Respiratory Distress Syndrome) Receiving IMV
• Intervention / Treatment: Drug: Types of drugs being delivered as aerosol therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 423

Contacts and Locations

• Study Contact: Name: piyush srivastava, MD; Phone Number: +91-9415107512; Email: drpiyush16@yahoo.co.in
• Study Contact Backup: Name: Sanjay Singhal, MD, EDRM, FCCP, PGDAST; Phone Number: +91-9198991155; Email: drsanjaysinghal79@yahoo.co.in

Study Locations

• India
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226008
      • Recruiting
      • Ts Misra Medical College
      • Contact: piyush srivastava, MD; Phone Number: +91-9415107512; Email: drpiyush16@yahoo.co.in
      • Contact: SANJAY SINGHAL, MD, FCCP, EDRM, FNIV, PGDAST; Phone Number: +91-9198991155; Email: drsanjaysinghal79@yahoo.co.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARDS PATIENTS; REQUIREING INVASIVE MECHANICAL VENTILATION	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	6 months

Collaborators and Investigators

• Sponsor: TS Misra Medical College
• Collaborators: Hospital General Universitario Morales Meseguer; Sanjay Gandhi Postgraduate Institute of Medical Sciences; Istanbul Medipol University Hospital; Ram Manohar Lohia Institute of Medical Sciences, Lucknow; HOSPITAL BRITANICO DE BUENOS AIRES; Casa di Cura del Policlinico di Milano; All India Institute of Medical Sciences; All India Institute of Medical Sciences, Raipur
• Investigators: Study Chair: Mohan Gurjjar, MD, SGPGIMS; Study Chair: Berkan Basancelebi, RT, PT, MSc, FNIV, Medipol University; Study Chair: 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; 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Estimated): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: ARDS; AEROSOL THERAPY; INVASIVE MECHANICAL VENTILATION
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID Numbers: TSMMC-2025-237(6)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 6 months after publication of manuscript and the data will be made accessible for up to 24 months
• IPD Sharing Access Criteria: qualified researchers engaging in independent scientific research
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No