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

NCT07269743 | Recruiting

• 1 other identifier: TSMMC-2025-237(6)
• Study Type: observational
• Target: 423
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS (Acute Respiratory Distress Syndrome) Receiving IMV

Keywords

ARDS; AEROSOL THERAPY; INVASIVE MECHANICAL VENTILATION

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Modality used for aerosol drug delivery

  6 MONTHS

• Types of aerosol generators used for aerosol drug delivery

  6 months

Study Arms (1)

ARDS PATIENTS

REQUIREING INVASIVE MECHANICAL VENTILATION

Drug: Types of drugs being delivered as aerosol therapy

Interventions

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.

ARDS PATIENTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Ts Misra Medical College

Lucknow, Uttar Pradesh, 226008, India

RECRUITING

Related Publications (2)

• 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.

  PMID: 41180103 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.

  PMID: 38687231 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Piyush srivastava, MD

CONTACT

+91-9415107512; drpiyush16@yahoo.co.in

Sanjay Singhal, MD, EDRM, FCCP, PGDAST

CONTACT

+91-9198991155; drsanjaysinghal79@yahoo.co.in

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR PIYUSH SRIVASTAVA

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after publication of manuscript and the data will be made accessible for up to 24 months
• Access Criteria: qualified researchers engaging in independent scientific research

Locations

IN (1)