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临床试验/NCT03361657
NCT03361657已完成不适用

Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries

Assiut University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2017年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Correlation between the Arterial to end-tidal carbon dioxide

研究概览

简要总结

Studying the arterial to end-tidal carbon dioxide difference in children undergoing laparoscopic surgeries under different intra-abdominal pressures is of extreme importance. This is because both hyper and hypocarbia are detrimental in this vulnerable age group.

详细描述

Capnography provides a non-invasive estimate of arterial CO2 levels and allows clinicians to modify mechanical ventilation settings in order to maintain normocapnia. Normally, a positive gap between arterial CO2 and ETCO2 of approximately 0.5 kPa is assumed in a healthy patient and ventilation settings are adjusted accordingly. However, the correlation between PaCO2 and PetCO2 during laparoscopic surgery is inconsistent mainly due to inter- and intra-individual variability. Discrepancies between arterial carbon dioxide and End-tidal carbon dioxide measures have been demonstrated in ventilated children with cyanotic congenital heart disease , infants with respiratory failure and during visceral and urological laparoscopic surgery. Moreover, as the increase in PaCO2 is directly proportional to the level of intra-abdominal pressure (IAP) used, variations in the arterial to end-tidal carbon dioxide difference can be also expected with different levels of IAP used.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Children with the following inclusion criteria;
  • Weight: 10-30 kg.
  • Age: 1-6 years.
  • Sex: both males and females.
  • ASA physical status: I, II.
  • Operation: elective laparoscopic surgeries that last more than 45 min.

排除标准

  • Patients will be excluded if they have;
  • Patients with any perioperative cardiovascular or respiratory event occurred which made the study intervention clinically unacceptable,
  • Patients with unsatisfactory preoperative peripheral arterial oxygen saturation,
  • Patients with unsatisfactory preoperative hemoglobin level, neurological or psychiatric disease,
  • Children with a BMI >95th percentile for age.

结局指标

主要结局

Correlation between the Arterial to end-tidal carbon dioxide

时间窗: Intraoperative

The arterial CO2 will be analysed from the blood gas and the endtidal carbon dioxide will be recorded from the capnography tracing.

次要结局

  • PaCO2-ETCO2 Difference(Intraoperative)
  • The noninvasive systolic and diastolic arterial blood pressure(intraoperative)
  • Heart rate(Intraoperative)

研究者

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

Hala Saad Abdel-Ghaffar

principal investigator

Assiut University

研究点 (1)

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