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临床试验/NCT04121572
NCT04121572招募中不适用

EtCO2 for Monitoring and Predicting Severity of DKA in Pediatric Emergency, Doha, Qatar.

Hamad Medical Corporation1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
To utilize capnography as a noninvasive tool for the detection and monitoring of DKA

研究概览

简要总结

Metabolic acidosis is one of the important and life-threatening pathophysiological changes in DKA and its monitoring is essential. It is known that the level of carbon dioxide (CO2) in the blood is correlating with the degree of metabolic acidosis. The CO2 level can be measured via the exhaled air by nasal cannula capnography (EtCO2) which is currently utilized to monitor the patient ventilation in many situations. Our primary objective is to study the degree of correlation between continuous EtCO2 monitoring and the severity of metabolic acidosis in blood gas measurement in patients with diabetic keto-acidosis (DKA). Secondary objectives are: ability of EtCO2 in ruling in or out DKA; discriminating the different severity grades of DKA. It is a cross-sectional, observational, prospective cohort study in convenience sample of children presenting with clinical manifestations consistent with DKA. Will be conducted in pediatric Emergency Center, Hamad General Hospital. Will include all DKA patients and excluding any condition or medication that affect the acid-base status.

详细描述

The study will be conducted in pediatric emergency center, Hamad General Hospital, a recognized academic institution, in Doha, Qatar.

The DKA was defined as: hyperglycemia (blood glucose >11 mmol/L or 200 mg/dL), venous pH <7.3 and/ or bicarbonate <15 mmol/L, and the association with, ketonemia, and ketonuria. The severity of DKA is categorized as mild (venous pH <7.3 or bicarbonate <15 mmol/L), moderate (venous pH <7.2 or bicarbonate < 10 mmol/L) and severe (venous pH < 7.1 or bicarbonate <5 mmol/L).

Eligible patients are all children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not.

The patients with the following criteria are excluded: older than 14 years of age, airway obstruction, chest infection, complex congenital heart disease, Congestive heart failure, central or peripheral neurological disorders, hyper/hypothermia, and sever pain.

Physicians and nurses, and research assistance staff will be trained in the use of nasal capnography including the proper size, connection and wave forms shapes and its interpretation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not.

排除标准

  • Older than 14 years of age
  • Airway obstruction
  • Chest infection
  • Complex congenital heart disease
  • Congestive heart failure
  • Central or peripheral neurological disorders
  • Hyper/hypothermia
  • Severe pain

结局指标

主要结局

To utilize capnography as a noninvasive tool for the detection and monitoring of DKA

时间窗: 2 years

Capnography measures exhaled CO2 which is an indicator of the presence and severity of metabolic acidosis caused by DKA.

次要结局

  • To find the ability of EtCO2 in ruling in or out DKA(2 years)

研究者

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

DR. KHALID AL-ANSARI

Director of Pediatric Emergency Center's

Hamad Medical Corporation

研究点 (1)

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