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临床试验/NCT03990337
NCT03990337Unknown不适用

Impact of Ultrasound-guided Identification of Cricoid Cartilage in Cricoid Pressure

Mount Sinai Hospital, Canada2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2018年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
130
试验地点
2
主要终点
Cricoid pressure effectiveness

研究概览

简要总结

This study is aimed to provide the evidence that ultrasound-guided identification of the cricoid cartilage can improve effectiveness of cricoid pressure. Ultrasound (US) is well recognized as a technique for identifying the neck landmarks including the cricoid cartilage. Based on the potential results that may show that US could be a tool for improve the effectiveness of cricoid pressure, the investigators expect to disseminate this knowledge to be transformed in the standard technique for helping anesthesiologists and nurses to do pressure in the correct location. It is expected that the greatest impact of this study will lead to improved patient outcomes and safety, particularly in the ones with high-risk for aspiration.

详细描述

This is a prospective two-arm randomized controlled single blinded study to be conducted at Mount Sinai Hospital, University of Toronto. The study will be conducted in the operating rooms (OR) with patients as subjects, and OR nurses and scheduled anesthesiologists as participants.Following signed informed consent, patients will be randomized into two groups:(i) Control group (CPG, n=65): cricoid pressure applied by the OR nurse on the cricoid cartilage using finger palpation without ultrasonography and (ii) Ultrasound group (USG, n=65): cricoid pressure applied by the OR nurse on the cricoid cartilage after localization with US. The oesophagus of the patient participants in both groups will also be identified by US. A portable US machine will be present in the operating room for all patients in both groups.

The anesthesiologist scheduled for the surgery is blinded to group allocation and will induce the patient with general anesthesia. The anesthesiologist will provide adequate oxygenation with 100% oxygen to reach an end-tidal oxygen ≥ 90% using mask ventilation. Thereafter, the scheduled anesthesiologist will step out of the operating room. Apneic oxygenation will be maintained using a nasal cannula with 100% oxygen at 5 litres/min. During apneic oxygenation, one of the research anesthesiologists will localize the cricoid cartilage using US (for patients in USG group). Prior to applying cricoid pressure, the nurse will be instructed to use an estimated pressure (of 30 Newtons) that causes discomfort when applied to his/her nasal bridge. The nurse will then apply an estimated 30 Newtons pressure on the cricoid cartilage localized by US for patients in the USG group or blindly without US for patients in CPG group.

The anesthesiologist will then return to the operating room and perform a videolaryngoscopy to directly visualize up to three attempts to pass a lubricated 20F gastric tube at the upper outlet of the esophagus with (i) pressure directly on the cricoid cartilage and (ii) with pressure on the cricoid cartilage shifted to the left and right of the midline. Following removal of the gastric tube and videolaryngoscope, the trachea will be intubated using direct laryngoscopy with a McIntosh blade. Cricoid pressure will be released after the cuff of the endotracheal tube is inflated. Thereafter, the location of the CC (blindly without US) for patients in CPG group will be marked and compared to the location that will be identified with US.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

盲法说明

Single-blinded

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 ≥ 18 years,
  • ASA physical status I and II,
  • body mass index <28 kg/m2,
  • scheduled to undergo surgical procedures requiring general anesthesia and endotracheal intubation.

排除标准

  • cardiac diseases,
  • respiratory diseases,
  • liver diseases,
  • gastroesophageal reflux symptoms,
  • anticipated difficult airway and/or anticipated difficult bag-mask ventilation

研究组 & 干预措施

Control group (CPG, n=65)

No Intervention

cricoid pressure applied by the OR nurse on the cricoid cartilage using finger palpation without ultrasonography

Ultrasound group (USG, n=65)

Active Comparator

cricoid pressure applied by the OR nurse on the cricoid cartilage after localization with ultrasonography

干预措施: Ultrasound (Device)

结局指标

主要结局

Cricoid pressure effectiveness

时间窗: 5 minutes

Cricoid pressure effectiveness defined as the failure to pass the gastric tube after 3 attempts

次要结局

  • Cormack-Lehane classification(5 minutes)
  • Cricoid pressure release(5 minutes)

研究者

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

Eric You-Ten

Associate Professor

Mount Sinai Hospital, Canada

研究点 (2)

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