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临床试验/NCT06361693
NCT06361693已完成不适用

"Observational Descriptive Study of Patient-performed Preoxygenation, the "Autopreoxygenation Concept""

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年10月14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
110
试验地点
1
主要终点
FeO2>90%

研究概览

简要总结

The aim of this research would be to determine the efficacy and effects of preoxygenation when performed by the patient (mask held by the patient).

This is the concept of "self-preoxygenation".

详细描述

Pre-oxygenation is a fundamental element of the induction sequence in anesthesia, described and recommended since 1955. Numerous studies have examined and compared the various techniques for implementing this procedure in terms of duration, objectives, equipment, patient characteristics and conditions. None of them specifies who should hold the mask when carrying out this recommendation. In everyday practice, patients are often asked to hold the mask themselves. A preliminary survey showed that 86% of patients are offered this option. The professionals questioned cited relational reasons (83%) above all, but also organizational reasons (43%).

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

  • Patient undergoing scheduled surgery with general anesthesia
  • Patient classified ASA I or II
  • Patient understanding and speaking French
  • Patient informed of the study and not opposed to it
  • Decision to have preoxygenation carried out by the patient.

排除标准

  • Patients with grade II or III obesity (BMI>35)
  • Patient with at least one respiratory comorbidity
  • Smoking patient
  • Pregnant patients
  • Patient with an allergy to one of the mask's components
  • Patient with cognitive impairment or known comprehension difficulties
  • Patient under guardianship or curatorship
  • Patient not affiliated to health care system

结局指标

主要结局

FeO2>90%

时间窗: 3 minuts after the beginning of auto-preoxygenation - Day 1

Percentage of patients achieving a FeO2\>90% in 3 min at 12L/min fresh gas flow on 100% oxygen. To Evaluate the efficacity of the self-preoxygenation Assessing the effectiveness of auto-preoxygenation

次要结局

  • APAIS anxiety score(At arrival in the Day Surgery Unit - Day 1)
  • Visual analog anxiety scale (VAS-A) score(At discharge from the Day Surgery Unit - Day 1)
  • Visual analog comfort scale (VAS-C) score(At discharge from the Day Surgery Unit - Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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