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临床试验/NCT07269743
NCT07269743招募中不适用

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

TS Misra Medical College1 个研究点 分布在 1 个国家目标入组 423 人开始时间: 2025年12月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
423
试验地点
1
主要终点
FREQUENCY OF AEROSOL THERAPY

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all newly admitted adult patients with a diagnosis of ARDS in the participating ICU
  • The patient requires mechanical ventilation.
  • Age ≥ 18 years
  • Informed consent (if required)

排除标准

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

研究组 & 干预措施

ARDS PATIENTS

REQUIREING INVASIVE MECHANICAL VENTILATION

干预措施: Types of drugs being delivered as aerosol therapy (Drug)

结局指标

主要结局

FREQUENCY OF AEROSOL THERAPY

时间窗: 6 MONTHS

HOW MANY ARDS PATIENTS WERE RECEIVING AEROSOL THERAPY

TYPES OF drug USED as aerosol therapy

时间窗: 6 MONTHS

HOW MANY TYPES OF DRUGS WERE USED AS AEROSOL THERAPY IN ARDS PATIENTS

frequency of aerosol therapy

时间窗: 6 MONTHS

FREQUENCY OF AEROSOL THERAPY IN ARDS PATIENTS ON IMV

types of drugs use as aerosol therapy

时间窗: 6 months

types of drugs use as aerosol therapy in ARDS patients while receiving Invasive Mechanical Ventilation

次要结局

  • Modality used for aerosol drug delivery(6 MONTHS)
  • Types of aerosol generators used for aerosol drug delivery(6 months)

研究者

发起方
TS Misra Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

PIYUSH SRIVASTAVA

DR PIYUSH SRIVASTAVA

TS Misra Medical College

研究点 (1)

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