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临床试验/NCT06207513
NCT06207513已完成不适用

Single-used Versus MultiPlE-used Endotracheal suCtIon cAtheters in Mechanically ventiLated ICU Patients: the SPECIAL-ICU Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Feasibility of intervention

研究概览

简要总结

In low and middle-income countries, open endotracheal suction catheters are used multiple times to perform suctioning due to limited resources [1,2]. Currently, there is limited evidence for using a new suction catheter for each suction pass, acknowledged in a review article of endotracheal suction procedures in paediatric populations [3]. Additionally, the latest artificial airway suctioning practice guidelines published by the American Association for Respiratory Care in 2022 did not mention any recommendations regarding suction catheter changing frequency [4]. The guidelines adopted a study conducted in 2001 which showed that reusing an open tracheal suctioning catheter is safe and cost effective [5]. Therefore, the current evidence of reusing suctioning catheters remains unclear, which rationalize the reason why some resource limited Intensive Care Units (ICUs) use the catheter multiple times during a 12-hour shift, and possibly explain the high ventilator associated pneumonia (VAP) incidence in these ICUs [1,2].

Therefore, this feasibility study will propose to explore whether single-used suction catheters or multiple used open endotracheal tracheal suctioning catheters flushed with chlorhexidine are associated with reduced VAP incidence and its impact on mechanically ventilated patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Adult patients (aged ≥ 18 years old) who are admitted to the ICU, intubated with an endotracheal tube and receiving mechanical ventilation support directly after intubation with an expected mechanical ventilation support of at least 48 hours.
  • All adults' patients meeting the above criteria whose relatives agree for them to be part of the study via deferred consent process

排除标准

  • Patients who have received already standard care at ICU admission (the use of an endotracheal suction catheter multiple times during endotracheal suction procedures)
  • Patients with contraindications to endotracheal suctioning procedure such as increased intracranial pressure, severe haemoptysis, and cerebrospinal fluid leaks.
  • Patients who are previously intubated during the current hospital admission.
  • Patients expected to receive mechanical ventilation less than 72 hours.
  • Patients diagnosed with pneumonia at ICU admission.
  • Patients having a Modified Clinical Pulmonary Infection Score (MCPIS) of 5 or greater.
  • Patients with atelectasis, ARDS, and pulmonary oedema.
  • Patients known to be allergic to chlorhexidine.
  • Patients whose family (next-of-kin) have not provided deferred consent within 48 hours after ICU admission will be excluded and standard care will be provided.

结局指标

主要结局

Feasibility of intervention

时间窗: through study completion, an average of 1 year

The feasibility and acceptability of the proposed intervention among healthcare professionals in study settings and determine methods for the design of a conclusive randomized controlled trial.

次要结局

  • Patients outcome(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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