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临床试验/NCT07157215
NCT07157215招募中不适用

An International Survey on the Use of NIV Outside the ICU (NIV-Safety Study)

Dr. Ram Manohar Lohia Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
prevalence of non-invasive ventilation (NIV) use outside the ICU

研究概览

简要总结

Non-invasive ventilation (NIV) is a way to support breathing using a mask or helmet instead of a breathing tube, and it is proven to reduce the need for intubation, save lives, shorten hospital stays, and lower costs. While NIV has long been used in intensive care units, it is now increasingly applied in emergency rooms, hospital wards, and long-term care facilities. However, global data on how it is used outside ICUs-such as which patients receive it, how well it works, and what barriers exist-is lacking. The NIV-Safety Study is a worldwide survey of doctors, nurses, and respiratory therapists to understand current practices, outcomes, and challenges of NIV use beyond the ICU. The findings aim to guide safer, more effective, and standardized use of NIV across different healthcare settings.

详细描述

BACKGROUND Non-invasive ventilation (NIV) has been an essential tool in respiratory care since its introduction and remains a cornerstone in managing respiratory failure. Evidence-based guidelines recommend NIV as the first-line treatment for acute episodes in four key conditions: COPD exacerbations, cardiogenic pulmonary edema, pulmonary infiltrates in immunocompromised patients, and as a weaning strategy for COPD patients post-extubation [1]. Over the years, NIV has been widely adopted for managing acute respiratory failure across various conditions [2]. It is an effective alternative to invasive mechanical ventilation, helping to prevent intubation and reducing the risk of reintubation after extubation. While traditionally used in intensive care units (ICUs), its application has expanded beyond the ICU to settings such as emergency departments, general wards, high-dependency units (HDUs), and long-term care facilities [3]. Early initiation of NIV has been shown to reduce the need for intubation, lower mortality rates in acute COPD exacerbations, and decrease both hospital costs and length of stay [4]. Despite these benefits, several challenges persist, including inconsistencies in clinical protocols, inadequate staff training, and disparities in resource availability across healthcare systems. Additionally, there is a significant gap in comprehensive global data on NIV use and patient outcomes in non-ICU settings [5]. Understanding the international landscape of NIV implementation, including current practices, protocols, and barriers, is essential for optimizing patient care and establishing standardized guidelines. The NIV-Safety Study aims to bridge this gap by evaluating the prevalence of non-invasive ventilation (NIV) use outside the intensive care unit (ICU), global trends, indications, and challenges associated with NIV use outside the ICU.

RATIONALE FOR CURRENT STUDY:

Early initiation of NIV has been shown to reduce the need for intubation, lower mortality rates in acute COPD exacerbations, and decrease both hospital costs and length of stay [4]. While traditionally used in intensive care units (ICUs), its application has expanded beyond the ICU to settings such as emergency departments, general wards, high-dependency units (HDUs), and long-term care facilities [3]. Despite these benefits, several challenges persist, including inconsistencies in clinical protocols, inadequate staff training, and disparities in resource availability across healthcare systems. Additionally, there is a significant gap in comprehensive global data on NIV use and patient outcomes in non-ICU settings [5]. Understanding the international landscape of NIV implementation, including current practices, protocols, and barriers, is essential for optimizing patient care and establishing standardized guidelines. To date, no study has examined the use of NIV outside the ICU. A lack of data hampers the transfer of the benefits of scientific research to patients. This study aimed to evaluate global trends, indications, and challenges associated with NIV use outside the ICU.

OBJECTIVE

  1. Primary To assess the prevalence of non-invasive ventilation (NIV) use outside the ICU
  2. Secondary

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

prevalence of non-invasive ventilation (NIV) use outside the ICU

时间窗: SIX MONTHS

To assess the prevalence of non-invasive ventilation (NIV) use outside the ICU

次要结局

  • Common conditions treated with NIV in non-ICU settings(SIX MONTHS)
  • outcomes of using NIV in non-ICU settings(six months)
  • Barriers and challenges faced while using NIV in non-ICU settings(six months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sanjay Singhal

sanjay

Dr. Ram Manohar Lohia Hospital

研究点 (1)

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