Ts Misra Medical College
Lucknow, Uttar Pradesh, 226008, India
Location status: Recruiting
Location contact
SANJAY SINGHAL, MD, FCCP, EDRM, FNIV, PGDAST
CONTACT
piyush srivastava, MD
CONTACT
NCT Number: NCT07269743
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Lucknow, Uttar Pradesh, 226008, India
Location status: Recruiting
SANJAY SINGHAL, MD, FCCP, EDRM, FNIV, PGDAST
CONTACT
piyush srivastava, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
all newly admitted adult patients with a diagnosis of ARDS in the participating ICU
Exclusion criteria
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.
Time frame: 6 MONTHS
HOW MANY ARDS PATIENTS WERE RECEIVING AEROSOL THERAPY
Time frame: 6 MONTHS
HOW MANY TYPES OF DRUGS WERE USED AS AEROSOL THERAPY IN ARDS PATIENTS
Time frame: 6 MONTHS
FREQUENCY OF AEROSOL THERAPY IN ARDS PATIENTS ON IMV
Time frame: 6 months
types of drugs use as aerosol therapy in ARDS patients while receiving Invasive Mechanical Ventilation
Time frame: 6 MONTHS
TYPES OF AEROSOL GENERATORS USED TO DELIVER AEROSOL THERAPY IN ARDS PATIENTS
Time frame: 6 months
Types of aerosol generators used for aerosol drug delivery in ARDS patients while receiving IMV
Contact information is provided by the study sponsor or research team.
Piyush srivastava, MD
CONTACT
Sanjay Singhal, MD, EDRM, FCCP, PGDAST
CONTACT
TS Misra Medical College
Other
To OBSERVE PRACTISE OF AEROSOL THERAPY IN ARDS PATIENTS (AERO-IN-ARDS)
Acronym: AERO-IN-ARDS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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