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临床试验/NCT03554863
NCT03554863已完成不适用

Does Optiflow Anesthesia Allow Anethesia Induction "Without Hands" ?

CMC Ambroise Paré4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
4
主要终点
Recourse to another ventilation technique

研究概览

简要总结

Preoxygenation remains an important determinant of morbidity and mortality in anesthesia despite advances in mask ventilation and difficult intubation management.

  1. The usual practice Preoxygenation prior to the injection of the anesthetic agents is the administration of pure oxygen to delay the occurrence of hypoxemia during the apnea phase and intubation maneuvers. It consists of applying a mask on the patient's face and allowing it to ventilate, ensuring a perfect seal of the device. The end of oxygen exhalation fraction is a good reflection of the alveolar oxygenation and a value of 95% corresponds to a "total" alveolar oxygenation. When this value is reached, the injection of the anesthetic agents (hypnotic, morphine and myorelaxant) leads to the loss of consciousness and apnea, which forces to continue the manual ventilation to the mask. Intubation is performed when the myorelaxation is complete.
  2. Anesthetic induction "without the hands" The Optiflow Anesthesia (Fisher and Paykel Healthcare, Auckland, New Zealand) device provides heated, Humidified High-Flow Nasal Oxygen.

The hypothesis of this study is that Humidified High-Flow Nasal Oxygen, should allow anesthetic induction without having to impose the patient the establishment of a facial mask for several minutes before anesthetic induction and the doctor anesthetist assisted ventilation with the mask before intubation.

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
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consent for participation
  • Affiliation to the french social security system
  • Patients benefit general anesthesia with oral intubation

排除标准

  • Pregnant or breastfeeding patients;
  • Patients with difficulty of ventilation by Optiflow AnesthesiaTM (facial trauma);
  • Patients under the protection of justice
  • Patients with drained or undrained pneumothorax;
  • Patients with a predicted difficulty of mask ventilation or intubation according to the clinical examination prior to inclusion (arne score ≥ 11) or when treating the patient in the operating room;
  • Patients with coronary heart disease, heart failure or respiratory failure;
  • Patients with intracranial pathology; patients with arterial oxygen saturation <95% in the open air;
  • Patients for whom the surgical procedure requires the installation of a double-lumen tube;
  • Patients requiring rapid sequence induction; patients for whom the induction can not be carried out by the sequence sufentanil, propofol, rocuronium;
  • Patients with sugammadex allergy;
  • Patients placed under judicial protection
  • Patients who have already been included in the study

结局指标

主要结局

Recourse to another ventilation technique

时间窗: During the preoxygenation-induction-intubation period (30 min)

The preoxygenation-induction-intubation period is filmed (audio and video recording) and the use of mask ventilation will be confirmed a posteriori from the audio / video recording by two reviewers.

次要结局

未报告次要终点

研究者

发起方
CMC Ambroise Paré
申办方类型
Other
责任方
Sponsor

研究点 (4)

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