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临床试验/NCT06127173
NCT06127173已完成不适用

Effect of Positive End Expiratory Pressure on Gastric Insufflation During Face Mask Induction of General Anesthesia in Children Undergoing Elective Surgery: A Prospective Randomized Controlled Study

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年10月10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
2
主要终点
Gastric residual volume immediately after intubation

研究概览

简要总结

The aim of our study is first to assess the effect of different PEEP levels on gastric volume using ultrasonography during induction of general anesthesia in children undergoing elective surgery

详细描述

Patients will be randomized into three groups:

  • Group (ZEEP) with PEEP level 0 cmH2O.
  • Group (PEEP 3) with PEEP level 3 cmH2O.
  • Group (PEEP 5) with PEEP level 5 cmH2O. The principal investigator will create a computer-generated random table for randomization and allocation which will be numbered in sequence and will be sealed in envelopes. An attending anesthesiologist will unfold the envelopes 10min before starting the procedure. The parents and a sonographer will be blinded to patient group allocation. The attending anesthesiologist will not be blinded; however, the attending anesthesiologist will not participate in the ultrasonography or data analysis.

Anesthetic technique:

All children will undergo routine preoperative investigations: Complete blood count and coagulation profile. First, children will enter the recovery room for examination as regards the fulfillment of inclusion criteria to be in the study or to be excluded from the study. Second, the children will be included in the study will be premedicated using midazolam 0.5 mg/kg IM and IM atropine 0.2 mg /kg. Then a baseline antral area for each child lying supine will be measured by a single anesthesiologist using GE, LOGIC-e Ultrasound device with a 4-8 MHz transducer. The gastric antrum will be obtained in the sagittal or parasagittal plane between the left lobe of the liver and the pancreas, at the level of the aorta or inferior vena cava. The transducer will be tilted and rotated perpendicular to the long axis of the antrum, after having the longitudinal (D1) and anteroposterior (D2) diameters of the gastric antrum, the cross sectional areal, (CSA) will be calculated as follows:

CSA = D1x D2 x p/4 Gastric volume will be obtained by a formula based on a study by perlas.15 Stomach volume (mL) = (27 + 14.6 CSA (cm2)) - (1.28*age (years)). After that, the lungs will be divided into three regions: anterior, lateral and posterior, using the anterior and posterior axillary lines as boundaries. The ultrasound transducer will be placed perpendicular or parallel to the rib cage, and each region of the lung will be scanned bilaterally. The ultrasound probe will be first placed perpendicular to the rib cage to look for pulmonary atelectasis, and then the ultrasound probe will be placed parallel to the rib cage to take images at the most obvious point of pulmornary atelectasis. The scoring criteria will be Pulmonary consolidation score (zero- no consolidation; 1-minimal parietal consolidation; 2-small consolidation; 3-large consolidation). Pulmonary atelectasis will be defined as a pulmonary consolidation score ≥2 in any region.

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
Double (Participant, Outcomes Assessor)

盲法说明

An attending anesthesiologist will unfold the envelopes 10min before starting the procedure. The children and the sonographer will be blinded to patient group allocation. The attending anesthesiologist will not be blinded; however, he will not participate in the ultrasonography or data analysis.

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged1 to 12 years old American Society of Anesthesiologists (ASA) physical status I or II Children will be scheduled for elective surgery under general anesthesia.

排除标准

  • Parental refusal Children with increased risk of regurgitation Known respiratory diseases or uncorrected congenital heart disease

结局指标

主要结局

Gastric residual volume immediately after intubation

时间窗: 15 minutes

ultrasound guided measurement of gastric residual volume immediately after intubation

次要结局

  • Lung Ultrasound Score(15 minutes)
  • Qualitative gastric antrum score(15 minutes)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Khaled Abdelfattah Abdallah Sarhan

principal investigator, Asst. professor of anesthesia, Cairo university

Kasr El Aini Hospital

研究点 (2)

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