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临床试验/NCT05688722
NCT05688722已完成不适用

Head Elevation During Pre-oxygenation Can Delay Desaturation Time in Indonesian Patients

Indonesia University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Desaturation time

研究概览

简要总结

This study is a randomized-controlled trial study comparing the association between several degree of head elevation and conventional position during pre-oxygenation to desaturation time in patients undergo endotracheal intubation with general anesthesia

详细描述

Preoxygenation anesthesia induction is an important part of airway management to reduce the risk of hypoxemia when the patient is apneic. The effectivity of preoxygenation is influenced by several things such as patient's head position. This study aimed to compare preoxygenation with head elevation 20°, 30° and 45° and conventional position to the time of desaturation before endotracheal intubation in patients undergoing general anesthesia. This was a randomized clinical trial of 56 patients, divided into four groups (conventional or 0° head elevation group, 20° head elevation group, 30° head elevation and 45° head elevation group). All subject was preoxygenated for 3 minutes with 100% oxygen. Induction of anesthesia was started with fentanyl, propofol, followed by rocuronium after the patient lost consciousness. Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes. There was a significant difference in mean desaturation time among the four groups (p = 0.011). The most significant different was in 45o head elevation group (p < 0.05). . In patients undergoing general anesthesia, pre-oxygenation with head elevation 20°, 30° and 45° slows down the time for desaturation before endotracheal intubation compared to the conventional position. The 45° head elevation has the best result.

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)

盲法说明

The care provider and investigator were not blinded.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •undergo endotracheal intubation with general anesthesia for elective surgery
  • •aged 18-60 years old
  • •ASA physical status 1-2 preoperatively

排除标准

  • •Patients with difficult airway, cardiopulmonary disease, anemia, grade II obesity, pregnant, history of hypersensitivity to induction agents
  • •Patients did not give consent to follow the study

研究组 & 干预措施

Control

Placebo Comparator

Patient positioned in supine conventional position

干预措施: Supine position (Procedure)

20 degree head elevation

Active Comparator

Patient positioned in 20 degree head elevation position

干预措施: 20 degree head elevation position (Procedure)

30 degree head elevation

Active Comparator

Patient positioned in 30 degree head elevation position

干预措施: 30 degree head elevation position (Procedure)

45 degree head elevation

Active Comparator

Patient positioned in 45 degree head elevation position

干预措施: 45 degree head elevation position (Procedure)

结局指标

主要结局

Desaturation time

时间窗: Right after induction until reach oxygen saturation 93% or 5 minutes time limit

Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes

次要结局

未报告次要终点

研究者

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

Ratna Farida Soenarto

Principal Investigator

Indonesia University

研究点 (1)

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