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临床试验/NCT06514690
NCT06514690招募中不适用

Postoperative Memories and Optimal Level of Sedation for Tracheal Intubation Using Fiberoptic Bronchoscopy/Vidolaryngoscopy in Patients With Anticipated Difficult Airway Undergoing Surgery

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年4月29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
100
试验地点
1
主要终点
Incidence of postperative memories

研究概览

简要总结

Antecedentes In patients with expected difficult airways undergoing surgery, tracheal intubation must be performed with a fiberoptic bronchoscope or video laryngoscope while keeping the patient awake and under the effects of anesthetic sedation.

Objective: To determine and compare the existence of postoperative memories of the patients and the different levels of sedation (Ramsay scale) obtained during the intubation procedure.

Methods Prospective observational study that includes 100 patients older than 18 years who are going to undergo surgery, who need fiberoptic bronchoscopy/videolaryngoscopy for tracheal intubation due to the planned difficult airway and intravenous sedation. Patients with an unexpected difficult airway, under 18 years of age and/or with cognitive impairment will be excluded. After checking the tracheal intubation, the general anesthesia indicated for each patient will be used.

Twenty-four hours after tracheal extubation, the patient will be questioned about the pain presented during the fiberoptic bronchoscopic/videolaryngoscopic procedure and postoperative memories based on a modified Brice questionnaire. At 30 days after surgery, the postoperative memories of the patients will be evaluated again by telephone interview.

详细描述

Background In patients with expected difficult airways undergoing surgery, tracheal intubation must be performed with a fiberoptic bronchoscope or video laryngoscope while keeping the patient awake and under the effects of anesthetic sedation. The intravenous sedation has the advantages of relieving anxiety, providing maximum comfort to the patient, facilitating examination, and producing amnesia of the episode. As an inconvenience, it can produce a depression of the respiratory system, fearsome in patients with expected difficult airway. Given the fear of the appearance of respiratory depression in these patients, the levels of sedation achieved are usually not very deep, and there may be pain and the presence of unpleasant postoperative memories in relation to the intubation technique using bronchoscopy/videolaryngoscopy.

Main objective: To determine and compare the existence of postoperative memories of patients who need conscious tracheal intubation, but under the effects of sedation, due to the planned difficult airway, depending on whether intubation was performed with a fiberoptic bronchoscope or video laryngoscope.

Secondary objective: To determine if there is a relationship between the appearance of postoperative memories and the different levels of sedation (Ramsay scale) obtained during the intubation procedure.

Other objectives: To determine if the duration of tracheal intubation time influences the incidence of postoperative memories. Determine the incidence of respiratory depression (SpO2 <90%) during the tracheal intubation procedure. Pain presented by patients during the procedure.

Methods Prospective observational study

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

  • Patients older than 18 years
  • Patients undergoing surgery
  • Patients with predicted difficult airway

排除标准

  • Patients under 18 years of age
  • Patients without cognitive disorders

结局指标

主要结局

Incidence of postperative memories

时间窗: 24 hours after tracheal extubation and 30 days after

* Determine and compare, between study groups, the existence of postoperative memories according to Brice's questionnaire, in patients who need conscious tracheal intubation, under the effects of intravenous sedation. * Determine and compare, between study groups, postoperative memories for each sedation level of the Ramsay scale.

次要结局

  • Determine other adverse effects:(during fiberoptic bronchoscopy/videolaryngoscopy procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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