Effect of Different Low Flow Rates on Gas Exchange in Anesthetized Children During Apnea A Single Blinded Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- rise of arterial pressure of carbon dioxide
研究概览
简要总结
Effect of Low flow apneic oxygenation in pediatrics on rate of accumulation of transcutaneous carbon dioxide also, had been studied, compared to high flow rates. Furthermore, a recent study in apneic anesthetized adult discussed the rate of accumulation of carbon dioxide in arterial blood during 4 min of apnea but, no study in pediatrics discussed the effect of different low flow rates on rate of carbon dioxide accumulation during a period of apnea.
Aim of the study: the authors aim to study the effect of different flow rates of low flow oxygenation during 3 min of apnea in anesthetized children on the rate of accumulation of carbon dioxide
详细描述
Introduction: During induction of general anesthesia using muscle relaxant, all patients experience a period of apnea which begins when mask ventilation is stopped prior to laryngoscopy and tracheal intubation and ends when ventilation is resumed. This period is a critical time as pediatrics especially infants and younger children are more liable for hypoxia than older children and adolescents. Hypoxia during this period of time in turn, had been proved to increase morbidity and mortality. Apneic oxygenation means uptake of oxygen by the blood from the lungs in the absence of spontaneous respiration or positive pressure ventilation, and its effectiveness in reducing the risk of hypoxemia during intubation in children had been proved. Many variables and outcomes had been studied during low flow apneic oxygenation in pediatrics and it was found that, it doesn't not only reduce the risk of hypoxemia but also prolongs of the safe apnea time up to 6 mins even when compared with high flow apneic oxygenation.
Anesthetic technique:
All children will undergo routine preoperative investigations: Complete blood count and coagulation profile. First, they will be examined as regards the fulfillment of inclusion criteria to be in the study or to be excluded from the study. Then, All children will receive premedication using midazolam 0.5 mg/kg intramuscular and intramuscular atropine 0.02 mg /kg.
Before induction of anaesthesia, patient characteristics and vital signs will be recorded {pulse oximetry, ECG, non-invasive blood pressure, end-tidal carbon dioxide}and will be applied all over the operation.
While establishing of IV access, all children will be preoxygenated using 6 liter/min of 100% O2 for 3 mins and if there will be a difficulty in obtaining an IV access, patients will be induced with inhaled sevoflurane followed by the placement of an IV cannula. Then, 2-3mg/Kg of Propofol, 1mcg/Kg of Fentanyl, and 0.3-0.5 mg/kg of Atracurium will be given. During induction of anesthesia an expert pediatric anesthesiologist will introduce an arterial radial cannula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Due to the clinically obvious oxygen administration modalities, study personnel in theatres cannot be blinded, but patients and parents will be blinded to group allocation.
入排标准
- 年龄范围
- 1 Year 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 to 6 years old weighting 10-20 kg.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Children will be scheduled for elective surgery under general anesthesia.
排除标准
- •Parent refusal
- •Patient required nasal intubation
- •Children with a cardio-respiratory disease like asthma or recent upper respiratory infection.
- •Obstructive sleep apnea, sepsis.
- •Children prone to hypoxia or hypercarbia, and upper airway obstruction.
- •Children reported to have nasal obstruction .
结局指标
主要结局
rise of arterial pressure of carbon dioxide
时间窗: between 60s and 180s time points of apnea
mmHg
次要结局
- Mean difference in arterial pressure of oxygen(at the end of apnea time)
- Time to oxygen desaturation(5 seconds after the onset of apnea)
- Number of patients reached 6 minutes of apnea(1 minute after end of apneic oxygenation)
- Pressure difference between the end-tidal carbon dioxide and the arterial carbon dioxide(Between the end of apnea and the preceding blood gas)
- Lowest recorded oxygen saturation(throughout the apneic oxygenation)
- Heart rate(During apnea time)
- Mean arterial blood pressure(During apnea time)
- Occurence of sore throat(in first postoperative day)
研究者
Yasser S Mostafa, MD
Lecturer of anesthesia
Fayoum University Hospital
