Aerosol medicine use in adults with ARDS on mechanical ventilators

To OBSERVE PRACTISE OF AEROSOL THERAPY IN ARDS PATIENTS (AERO-IN-ARDS)

This project will see how aerosol medicines are used and tolerated in adults with ARDS who need invasive mechanical ventilation.

Quick facts

• Study type: Observational
• Enrollment: 423 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: TS Misra Medical College (Academic / other)
• Locations: 1 site (Lucknow, Uttar Pradesh)
• Trial ID: NCT07269743 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, international observational cohort that will enroll consecutive adults with ARDS who require invasive mechanical ventilation at participating ICUs. Each center will screen patients during a six-month inclusion window (or up to 25 patients per center) and follow enrolled patients for 14 days or until ICU discharge, death, or successful weaning from mechanical ventilation. The study will record which aerosol drugs are delivered, delivery methods, frequency of use, and safety signals such as electrolyte or cardiac abnormalities. The protocol will be reported according to STROBE guidance to provide representative real-world data on aerosol use in ARDS.

Who should consider this trial

Good fit: Adults aged 18 or older with a diagnosis of ARDS who require invasive mechanical ventilation in a participating ICU (with informed consent or legal representative consent where required) are eligible.

Not a fit: Patients managed with noninvasive ventilation or high-flow nasal oxygen, and children under 18, are excluded and therefore will not directly benefit from this study's findings.

Why it matters

Potential benefit: If successful, this study could clarify how often and how safely aerosol therapy is used in ventilated ARDS patients and identify practice patterns or subgroups that may warrant further trials.

How similar studies have performed: Early laboratory and small clinical studies suggested possible benefits of inhaled beta-2 agonists and corticosteroids, but larger randomized trials have not shown clear clinical benefit and guidelines remain noncommittal.

Eligibility criteria

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

Where this trial is running

Lucknow, Uttar Pradesh

• Ts Misra Medical College — Lucknow, Uttar Pradesh, India (Recruiting)

Study contacts

• Study coordinator: Piyush srivastava, MD

Conditions ARDS Receiving IMV; ARDS; AEROSOL THERAPY; INVASIVE MECHANICAL VENTILATION