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临床试验/NCT05005390
NCT05005390已完成不适用

Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway:A Prospective Randomized and Blinded Trial.

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2021年7月26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
147
试验地点
2
主要终点
Number of Patients With Successful Ventilation

研究概览

简要总结

The purpose of this study is to determine the efficacy of TTIP-first ventilation and to compare the efficacy of TTIP first ventilation with the current practice of mask-first ventilation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, 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

  • BMI >30 kg/m2
  • Mallampati class III or IV
  • Requiring general anesthesia

排除标准

  • Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease(COPD)and asthma
  • American Society of Anesthesiologists (ASA)physical status classification ≥IV
  • Emergency surgery
  • Induction requiring rapid sequence for intubation
  • Patients requiring awake intubation
  • Pregnant women
  • Untreated ischemic heart disease
  • Contraindication for mask ventilation

结局指标

主要结局

Number of Patients With Successful Ventilation

时间窗: from start of ventilation to end of ventilation (about 1 minute)

Successful ventilation is defined as expired carbon dioxide with three phases in at least one of the first three consecutive breaths.

次要结局

  • Peak Inspiratory Airway Pressure Achieved(from start of ventilation to end of ventilation (about 1 minute))
  • Dynamic Airway Resistance(from start of ventilation to end of ventilation (about 1 minute))
  • Expired Tidal Volume of Ventilation(from start of ventilation to end of ventilation (about 1 minute))
  • Satisfaction of the Providers Obtained With Post Ventilation Survey(end of surgery (about 1 hour after start))

研究者

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

Travis Markham

Assistant Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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