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临床试验/NCT05850988
NCT05850988已完成不适用

Effects of Different Oxygen Concentrations for Preoxygenation on Lung Ultrasound Scores During Spontaneous Ventilation

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年4月15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
50
试验地点
1
主要终点
Change of Modified Lung Ultrasound Scores

研究概览

简要总结

The goal of this study is to observe the effects of different oxygen concentrations during preoxygenation in spontaneous breathing patients with modified lung ultrasound scores before induction of general anesthesia. Preoxygenation is a routine and recommended procedure for patients undergoing general anesthesia. Atelectasis is a common side effect of general anesthesia and usage of high concentration oxygen is a probable cause of it. Using lower oxygen concentrations in preoxygenation may help reducing the atelectasis and it can be assessed by lung ultrasound.

详细描述

Preoxygenation is the process of supplying the patient a high inspired fraction of oxygen prior to an airway intervention or induction of general anesthesia. Prolonging safe apnea duration is the primary aim of preoxygenation and preoxygenation is recommended for all patients before induction of general anesthesia.

Atelectasis is the most common postoperative pulmonary complication and is associated with usage of high inspired fraction of oxygen. Modified lung ultrasound scoring is an effective and noninvasive method to determine atelectasis. In this study we will observe the effects of different oxygen concentrations during preoxygenation before induction of general anesthesia in spontaneous breathing patients with modified lung ultrasound scores .

Patients undergoing general anesthesia for elective surgery meeting the criteria will be acknowledged about the study. After written consents are taken patients will be randomised into two groups by coin method. One group will receive %80 oxygen for 3 minutes and other group will receive %100 oxygen for 3 minutes during preoxygenation. Each participants demographic data will be collected. 12 quadrants of thorax divided by midsternal line, anterior axillary and posterior axillary lines will be examined by the usage of modified lung ultrasound score before and at the end of preoxygenation for all individuals. Randomisation, lung ultrasound scoring and preoxygenation will be done by different experienced anesthesiologists so the observers of this study would be blinded for the results. Patients will be blinded for the concentration of oxygen. Modified lung scores of each group would be compared at the end of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •American Society of Anesthesiologists Score I and II
  • •Being a candidate to elective surgery under general anesthesia

排除标准

  • •Patients with any pulmonary disease
  • •Patients who had pulmonary infection in the past 3 months
  • •Patients who had a surgery in the past 3 months
  • •Patients who had a multitrauma in the past 3 months
  • •Patients who have a Body Mass Index over 30
  • •Pregnants
  • •Patients who have diaphragma hernia
  • •Patients who have gastroesophageal reflux disease

研究组 & 干预措施

Group Eighty

Active Comparator

Patients in Group E will receive %80 oxygen for 3 minutes during preoxygenation

干预措施: %80 Oxygen concentration (Other)

Group Hundred

Active Comparator

Patients in Group H will receive %100 oxygen for 3 minutes during preoxygenation

干预措施: %100 Oxygen concentration (Other)

结局指标

主要结局

Change of Modified Lung Ultrasound Scores

时间窗: 3 minutes

Scores between 0-3 for 12 thorax quadrants and total score will be recorded for each participants before and after a 3 minutes time of preoxygenation to assess change from baseline

次要结局

  • End-Tidal Oxygen levels(3 minutes)

研究者

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

derya özkan

Professor M.D.

Diskapi Teaching and Research Hospital

研究点 (1)

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