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临床试验/NCT05780385
NCT05780385已完成不适用

Nasotracheal Intubation Vs. Conventional Airway Management in Critically Ill Patients.

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2023年2月10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
126
试验地点
2
主要终点
Sedation depth

研究概览

简要总结

The aim of this prospective randomized trail is to compare nasotracheal versus orotracheal intubation in critically ill patients. We aim to study:

  • required sedation depth
  • rate of spontaneous breathing
  • extend and possibility of physiotherapy
  • vasopressor and sedative drug doses

Participants are randomized 1:1 to receive either nasotracheal or orotracheal intubation.

详细描述

In the intensive care unit endotracheal intubation and consecutive mechanical ventilation are required for different surgical procedures, examinations and interventions in the ICU or due to respiratory insufficiency. Commonly, intubation is performed orotracheally by direct laryngoscopy after preoxygenation and administration of narcotics and a muscle relaxant. When using this technique sedation is often necessary for tolerance of the orotracheal tube. To avoid the adverse side effects of sedation and mechanical ventilation as for example hypotension, barotrauma, ventilator associated pneumonia, etc., intubation via a nasotracheal approach might be favorable. Retrospective data show that nasotracheal intubation is associated with fewer sedatives, vasopressors, and a higher rate of spontaneous breathing. As there is a paucity of data concerning the use of nasotracheal intubation in the intensive care setting the investigators aim to compare the use of orotracheal and nasotracheal tubes in a prospective randomized trial, using sedation depth as primary outcome measure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • Patients requiring tracheal intubation during their intensive care stay.

排除标准

  • orotracheal or nasotracheal route of intubation technically not possible (e.g. confirmed indication for awake fiberoptic intubation due to expected difficult airway)
  • tracheal intubation indicated for deep sedation (e.g. treatment of elevated intracranial pressure)
  • thrombocytopenia < 50/nl or other risk factors for bleeding
  • pregnant or breastfeeding women
  • denial of consent

结局指标

主要结局

Sedation depth

时间窗: intubation to 72 hours

fraction of time with a Richmond Agitation and Sedation Scale (RASS) of 0 or -1. Range -5 to +4 with 0 as optimum value representing awake and alert patient.

次要结局

  • time to extubation(intubation to day 30)
  • vasopressor therapy(intubation to day 10)
  • sinusitis(intubation to day 30)
  • rate of extubation(intubation to day 30)
  • tracheostomy(intubation to day 30)
  • sedative drugs(intubation to day 10)
  • ventilator associated pneumonia(intubation to day 30)
  • length of intensive care stay(intubation to day 30)
  • complications(intubation to day 1)
  • mortality(intubation to day 30)
  • Sedation depth(intubation to day 10)
  • spontaneous breathing(intubation to day 10)
  • physiotherapy(intubation to day 10)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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