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临床试验/CTRI/2025/12/099492
CTRI/2025/12/099492尚未招募不适用

Economic and Clinical Impact of Automated Suction device on VAP prevention in Mechanically Ventilated Neurocritical Care Patients. A Randomized Controlled Non-Inferiority trial

NIMHANS1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NIMHANS
入组人数
80
试验地点
1

研究概览

简要总结

Ventilator associated pneumonia is a common and preventable hospital acquired infection among mechanically ventilated patients and leads to prolonged ICU stay increased antibiotic use and higher healthcare costs. Neurocritical care patients are at particularly high risk because they require longer ventilation and intensive monitoring resulting in a greater economic burden. Although standard ventilator associated pneumonia prevention bundles are effective adherence is variable and manual suctioning increases nursing workload. Automated airway management systems such as Automated Oropharyngeal and Subglottic Suction AOPS may improve secretion clearance reduce ventilator associated pneumonia incidence shorten ventilation duration lessen antibiotic requirements and lower ICU costs. However evidence on their economic impact in neurocritical care is limited.

This single centre open label prospective randomized non inferiority study will be conducted in the ICU at NIMHANS Bangalore. Adult neurointerventional and neurosurgical patients requiring mechanical ventilation will be randomized to automated suctioning or conventional manual suctioning. All patients will receive standard ventilator associated pneumonia prevention measures. The study will compare average per day direct ICU costs as the primary outcome. Secondary outcomes include costs of medications diagnostics consumables equipment human resource utilization duration of ventilation antibiotic use escalation patterns ICU stay investigation frequency and safety outcomes. Indirect patient costs such as loss of wages will also be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted to Neuro critical care ICU requiring mechanical ventilation.

排除标准

  • Patients with tracheostomy, latex allergy, oropharyngeal bleeding or bleeding disorders, faciomaxillary or cervical spine injuries Patients admitted with primary lung pathology.
  • Severe immune dysfunction Non provision of consent for participation in the study by self or relatives.
  • Vulnerable populations such as patients with mental illness, physical disabilities, elderly individuals, pregnant or lactating women, patients with chronic neurological disorders and terminally ill patients will be excluded from study.

研究者

发起方
NIMHANS
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Manisha J

NIMHANS

研究点 (1)

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