ARDS (Acute Respiratory Distress Syndrome) Receiving IMVAERO-IN-ARDSNCT07269743
AEROSOL THERAPY IN ARDS PATIENTS (AERO-IN-ARDS)
An observational study of ARDS (Acute Respiratory Distress Syndrome) Receiving IMV, run by TS Misra Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome) Receiving IMV
- What is being tested?
- Types of drugs being delivered as aerosol therapy
- How many people
- 423 participants
- Where
- 1 siteIndia
- Study dates
- 10 Dec 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Age <18 years
- Patients managed with NIV, and HFNO
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Ts Misra Medical College
Lucknow, Uttar Pradesh, 226008
SANJAY SINGHAL, MD, FCCP, EDRM, FNIV, PGDAST, +91-9198991155, drsanjaysinghal79@yahoo.co.in
piyush srivastava, MD, +91-9415107512, drpiyush16@yahoo.co.in
About this study
Official title: 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.
Read the 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.
- Being tested
- Types of drugs being delivered as aerosol therapy
- Keywords
- ARDS, AEROSOL THERAPY, INVASIVE MECHANICAL VENTILATION
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Types of drugs being delivered as aerosol therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ARDS PATIENTS | REQUIREING INVASIVE MECHANICAL VENTILATION Receives: Drug: Types of drugs being delivered as aerosol therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
FREQUENCY OF AEROSOL THERAPY
HOW MANY ARDS PATIENTS WERE RECEIVING AEROSOL THERAPY
Measured: 6 MONTHS
TYPES OF drug USED as aerosol therapy
HOW MANY TYPES OF DRUGS WERE USED AS AEROSOL THERAPY IN ARDS PATIENTS
Measured: 6 MONTHS
frequency of aerosol therapy
FREQUENCY OF AEROSOL THERAPY IN ARDS PATIENTS ON IMV
Measured: 6 MONTHS
types of drugs use as aerosol therapy
types of drugs use as aerosol therapy in ARDS patients while receiving Invasive Mechanical Ventilation
Measured: 6 months
Secondary outcomes (2)
Modality used for aerosol drug delivery
TYPES OF AEROSOL GENERATORS USED TO DELIVER AEROSOL THERAPY IN ARDS PATIENTS
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ARDS (Acute Respiratory Distress Syndrome) Receiving IMVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 423 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TS Misra Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences, All India Institute of Medical Sciences, Raipur, Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Hospital General Universitario Morales Meseguer, Istanbul Medipol University Hospital, Casa di Cura del Policlinico di Milano, HOSPITAL BRITANICO DE BUENOS AIRES
- Responsible party
- Principal investigator, PIYUSH SRIVASTAVA, TS Misra Medical College
- Investigators
- Mohan Gurjjar, MD, Study chair, SGPGIMSBerkan Basancelebi, RT, PT, MSc, FNIV, Study chair, Medipol UniversityGustavo Plotnikow, BPT, BCs, PhD(c), 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, ArgentinaGiuseppe Francesco Sferrazza Papa, MD PhD, Study chair, Casa di cura policlinico, department of rehabilitation sciences, Milan, (Italy)Salvatore Notaro, MD, Study chair, AORN colli HospitalsAntonio M Esquinas, MD, PhD, FCCP, FNIV, FBCV, Study chair, Instituto Murciano de Investigacion Biosanitaria, Murcia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269743
- Sponsor's protocol ID
- TSMMC-2025-237(6)
- Acronym
- AERO-IN-ARDS
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 41180103Singhal 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.
PubMed 38687231
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To OBSERVE PRACTISE OF AEROSOL THERAPY IN ARDS PATIENTS (AERO-IN-ARDS)
- ClinicalTrials.gov ID
- NCT07269743
- Acronym / sponsor ID
- AERO-IN-ARDS / TSMMC-2025-237(6)
- Keywords
- ARDS, AEROSOL THERAPY, INVASIVE MECHANICAL VENTILATION
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 423 participants (estimated)
- Lead sponsor
- TS Misra Medical CollegeUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences, All India Institute of Medical Sciences, Raipur, Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Hospital General Universitario Morales Meseguer, Istanbul Medipol University Hospital, Casa di Cura del Policlinico di Milano, HOSPITAL BRITANICO DE BUENOS AIRES
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS PATIENTS | – | Drug: Types of drugs being delivered as aerosol therapyREQUIREING INVASIVE MECHANICAL VENTILATION |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Age <18 years
- Patients managed with NIV, and HFNO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Types of drugs being delivered as aerosol therapyEvery 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. | Drug | ARDS PATIENTS |
Primary outcome
FREQUENCY OF AEROSOL THERAPY
Time frame: 6 MONTHS
HOW MANY ARDS PATIENTS WERE RECEIVING AEROSOL THERAPY
TYPES OF drug USED as aerosol therapy
Time frame: 6 MONTHS
HOW MANY TYPES OF DRUGS WERE USED AS AEROSOL THERAPY IN ARDS PATIENTS
frequency of aerosol therapy
Time frame: 6 MONTHS
FREQUENCY OF AEROSOL THERAPY IN ARDS PATIENTS ON IMV
types of drugs use as aerosol therapy
Time frame: 6 months
types of drugs use as aerosol therapy in ARDS patients while receiving Invasive Mechanical Ventilation
2 secondary outcomes
Modality used for aerosol drug delivery
Time frame: 6 MONTHS
Types of aerosol generators used for aerosol drug delivery
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 41180103Singhal 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.
- Background: PubMed 38687231Singhal 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohan Gurjjar, MD study chair
SGPGIMS
Berkan Basancelebi, RT, PT, MSc, FNIV study chair
Medipol University
Gustavo Plotnikow, BPT, BCs, PhD(c) 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS (Acute Respiratory Distress Syndrome) Receiving IMV, run by TS Misra Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piyush srivastava, MD (+91-9415107512, drpiyush16@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FREQUENCY OF AEROSOL THERAPY (time frame: 6 MONTHS). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07269743, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.