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临床试验/NCT02238691
NCT02238691已完成不适用

Risk of Gastric Insufflation Related to Facemask Ventilation Technique During Anaesthetic Induction

Örebro University, Sweden2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年2月1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
30
试验地点
2
主要终点
Level of inspiratory pressure for gastric insufflation

研究概览

简要总结

Continuous positive pressure during anesthetic induction is today not routinely used partly a to the risk of gastric insufflation because of higher ventilatory pressures. However there are conflicting data with improvement of GERD symptoms in CPAP treated OSA patients. The investigators aim to compare the risk of gastric insufflation regarding mask ventilation technique, with or without positive end expiratory pressure. For measurements a High Resolution Impedance Manometry Catheter is used.

详细描述

Anesthetic induction agents cause a number of physiological changes within the respiratory system. Almost every induction agent causes apnoea. There is a reduction of FRC and an increase in airway resistance. Combined with preoxygenation with a high fraction of oxygen there is a significant risk of pulmonary atelectasis. Adding a continuous positive pressure during ventilation of the apnoeic patient improves many of the respiratory effects caused by induction agents. However the added continuous pressure will increase the total inspiratory pressure and a high inspiratory pressure is associated with an increased risk of gastric insufflation during mask ventilation. On the other hand there are data suggesting that continuous positive pressure is beneficial in treatment of GERD-symptoms.

The investigators hypothesis is, if performed correctly, that the continuous positive pressure will not increase the risk of gastric insufflation. In order to investigate this matter 30 healthy human subjects will undergo anesthetic induction, 15 with no PEEP added and 15 with a PEEP of 10 cm H2O during mask ventilation.

Protocol:

  1. Preoxygenation, 100 % oxygen via Face mask for 3 minutes with 0 PEEP or 10 cm H2O PEEP.
  2. Start of Remifentanil Target Controlled Infusion, target concentration 6 ng/ml.
  3. Propofol 2-2.5mg/kg to adequate depth of anesthesia.
  4. 30 seconds after apnea mask ventilation with Dräger ZEUS IE starting with an inspiratory pressure of 3cm H2O that is gradually increased to a maximum of 30 cm H20 or to signs of air insufflation in the esophagus. Group 1 with 0 PEEP and group 2 with 10 cm H2O PEEP.
  5. End of Remifentanil- and Propofol infusion.

Pressures and passage of air or liquid from pharynx to stomach will be continuously registered during the procedure. For measurements a High Resolution Impedance Manometry Catheter with the ability to measure pressures and impedance simultaneously will be used.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female age 18-40 years
  • Signed and informed consent
  • Subject will and is assumed to be able to follow protocol

排除标准

  • Known gastro intestinal/heart/lung/kidney or neurological disease
  • Use of drugs that interfere with esophageal motility
  • Pregnancy or breastfeeding

结局指标

主要结局

Level of inspiratory pressure for gastric insufflation

时间窗: One hour

次要结局

  • Pressure changes in the esophagus related to ventilation technique.(One hour)

研究者

发起方
Örebro University, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex de Leon

PhD

Örebro University, Sweden

研究点 (2)

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