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临床试验/NCT03432390
NCT03432390已完成不适用

Continuous Positive Airway Pressure During General Anesthesia Induction For Elective Pediatric Surgery: Randomized Clinical Trial

Instituto Materno Infantil Prof. Fernando Figueira1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年3月6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
72
试验地点
1
主要终点
Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels

研究概览

简要总结

SCENARIO: Hypoxemia is one of the most common adverse events during the induction of general anesthesia and may culminate with more serious complications such as cardiac arrest and death. Pediatric patients, due to their anatomical and physiological characteristics, are more likely to develop hemoglobin desaturation levels. Some preventive strategies are used during this period to reduce the chances of occurrence of adverse event. Continuous Positive Airway Pressure (CPAP) may be useful during anesthetic induction in delaying the drop in oxygen levels in the blood by increasing this body gas reserves. OBJECTIVES: To assess the effectiveness of CPAP during anesthetic induction in increasing apnea time until hemoglobin saturation falls to 95% in children undergoing general anesthesia for elective surgery. METHODS: Phase III, parallel, randomized clinical trial to be developed at the Teaching Hospital of the Federal University of Pernambuco. Patients (72) are divided into two groups (36 in each) in which all patients will spontaneously ventilate: group C will receive CPAP and group A will use the open system. Children of pre-school age with physical status I or II, according to the American Anesthesia Society, candidates for elective surgery under general anesthesia will be included. Patients with pre-existing parenchymal lung disease, cyanotic children or patients with oxyhemoglobin saturation <95% prior to anesthetic induction and recent history (<4 weeks) or active upper respiratory tract infection will be excluded. The descriptive statistical analysis will be carried out through measures of central tendency and dispersion for quantitative variables and via distribution of frequencies for qualitative variables. ETHICAL ASPECTS: This work will respect human rights, principles of bioethics, the resolution 466/2012 of the National Health Council and the statement from Helsinki. Submission and approval by the research ethics committee is required prior to data collection. KEYWORDS: Continuous Positive Airway Pressure, Hypoxia, General Anesthesia

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pre-school children, ASA physical status I or II, Children undergoing general anesthesia for elective surgery

排除标准

  • Pre-existing parenchymal lung disease, Children cyanotic or with oxyhemoglobin saturation less than 95% before anesthetic induction, Recent history (<4 weeks) or current upper respiratory tract infection

结局指标

主要结局

Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels

时间窗: During induction of general anesthesia (up to five minutes after beginning of apnea)

In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare the time between onset of apnea and the drop in 95% oxyhemoglobin saturation between the groups

次要结局

  • Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry(During induction of general anesthesia (up to five minutes after beginning of apnea))
  • Number of Participants That Experienced Complications While Undergoing General Anesthesia(During induction of general anesthesia (up to five minutes after beginning of apnea))

研究者

发起方
Instituto Materno Infantil Prof. Fernando Figueira
申办方类型
Other
责任方
Principal Investigator
主要研究者

Flavia orange

PhD, Clinical Professor

Instituto Materno Infantil Prof. Fernando Figueira

研究点 (1)

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