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临床试验/NCT04552028
NCT04552028Unknown不适用

Correlation of Non-invasive and Invasive Oxygenation for the Diagnosis of Respiratory Dysfunction in Acute Pancreatitis

Dr. med. Hector Eloy Tamez Perez1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2019年12月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
74
试验地点
1
主要终点
To determine if the SpO2 / FIO2 ratio has a correlation with PaO2 / FIO2 ratio to identify respiratory compromise in acute pancreatitis.

研究概览

简要总结

Acute pancreatitis (AP) is an inflammatory process of the pancreas and is one of the main causes of hospital admission of gastrointestinal origin. The annual incidence is between 13 to 45 per 100,000 habitants. The etiology may correspond to vesicular gallstones, excessive alcohol consumption, drugs, among others. Risk factors such as smoking and type 2 diabetes mellitus have been found to increase the risk of pancreatitis by 1.86 to 2.89 times.

Pulmonary complications are the most frequent in this group of patients, approximately in 75% of cases, they vary from hypoxemia to acute respiratory distress syndrome (ARDS). In the first 2 days of hospital admission, tachypnea, mild respiratory alkalosis and hypoxemia may occur, usually without radiological manifestations, however 33% of patients with AP have pulmonary complications with symtoms and radiological signs, some of them are atelectasis (15%), small pleural effusion (4-17%) mainly of right lung and pulmonary edema (8-50%).

Non-invasive methods would allow faster identification of patients with hypoxemia or patients who have pulmonary organ failure. (6) There is no evidence on the usefulness of SpO2 / FiO2 (SF) as a predictor of hypoxemia and its correlation with PaO2 / FiO2 in acute pancreatitis, however its continuous calculation can greatly reduce arterial gas intake and decrease adverse events and costs.

详细描述

Basal period

Patients will be managed based on the most current acute pancreatitis clinical guidelines and the requirements will be:

  • Complete medical history including: sex, age, history of chronic degenerative diseases, pulmonary and/or cardiac diseases, alcohol consumption, onset of abdominal pain, body mass index.

  • Laboratory tests: blood count, biochemical profile, amylase and serum lipase, complete serum electrolytes, lipid profile, arterial blood gases.

  • Image studies:

  • Ultrasound of the upper abdomen to rule out biliary etiology

  • Computed tomography of simple abdomen in case of diagnostic doubt

  • Chest radiography

  • Pulse oximetry with Finger Pulse Oximeter Brand: Carejoy Model G11002

  • Severity of acute pancreatitis as follows:

  • Severity will be established based on the revised Atlanta 2012 Criteria.

  • The modified Marshall system will be evaluated to determine organic failure, which is defined as: ≥ 2 points in any of the 3 organic systems evaluated (renal, cardiovascular and pulmonary).

  • Variables will be obtained to determine systemic inflammatory response syndrome.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with acute pancreatitis with clinical, radiological or laboratory criteria.
  • All genders
  • Acute pancreatitis of any aetiology
  • Over 18 years old

排除标准

  • Lung diseases
  • Heart failure
  • Cholangitis
  • Acute cholecystitis
  • Pregnancy
  • Refuse to participate

结局指标

主要结局

To determine if the SpO2 / FIO2 ratio has a correlation with PaO2 / FIO2 ratio to identify respiratory compromise in acute pancreatitis.

时间窗: 5 days

Pulse oximetry will be performed at the same time as arterial blood gases, to calculate the SP ratio at admission and every 24 hours, until resolution of pancreatitis and/or the first 5 days of hospitalization.

次要结局

未报告次要终点

研究者

发起方
Dr. med. Hector Eloy Tamez Perez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. med. Hector Eloy Tamez Perez

Clinical Professor

Hospital Universitario Dr. Jose E. Gonzalez

研究点 (1)

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