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临床试验/NCT04895527
NCT04895527已完成不适用

Air-test as a Predictor of Pulmonary and Systemic Complications After Laparoscopic Surgery

Dr. Negrin University Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年6月1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
250
试验地点
1
主要终点
Postoperative pulmonary complications

研究概览

简要总结

One of the main risk factors for the development of postoperative pulmonary complications (PPC) in postsurgical patients is the persistence of atelectasis during this period. Therefore, it would be of great clinical interest to establish a causal relationship between postoperative atelectasis and the development of PPC, as well as having a relatively precise, simple and non-invasive method to rapidly diagnose these atelectasis.

A prospective observational study will be carried out including all patients undergoing scheduled laparoscopic surgery, excluding pregnant women or women in the period of lactation, patients with moderate - severe acute respiratory distress syndrome, heart failure, need for mechanical ventilation during the 15 days prior to surgery or with a history of cardiothoracic surgery. Demographic variables (age, sex, weight, BMI), preoperative data (presence of allergies, cardiovascular risk factors, personal cardiopulmonary history, presence of toxic habits, baseline peripheral oxygen saturation, ASA classification, ARISCAT and frailty markers will be collected - Fried phenotype, scale clinical frailty and FRAIL scale -) and intraoperative (duration of the procedure, recruitment maneuvers). At 30 postoperative days the history will be reviewed clinic of the patients and the postoperative complications will be collected. Main objective: to demonstrate the veracity of the air-test in the prevention of pulmonary or other systemic complications in patients undergoing laparoscopic surgery.

Secondary objectives:

  • Measure the incidence of positive results in the air-test.
  • Demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test
  • Demonstrate the correlation between the degree of frailty of the patients and a positive score in the air-test.

详细描述

The persistence of postsurgical atelectasis is potentially associated with complications such as pneumonia, acute respiratory distress, and hypoxemia. This promotes other systemic complications such as myocardial ischemia or healing defects, negatively affecting morbidity, healthcare costs, and postoperative survival. Pre and intraoperative hemoglobin saturation levels are an independent risk factor for postoperative pulmonary complications. The airtest, based on the measurement of peripheral oxygen saturation (SpO2) with ambient air in the early postoperative period, is a useful tool in the prevention of moderate-severe pulmonary postsurgical complications.

One of the main risk factors for the development of postoperative pulmonary complications (PPC) in postsurgical patients is the persistence of atelectasis during this period. Therefore, it would be of great clinical interest to establish a causal relationship between postoperative atelectasis and the development of PPC, as well as having a relatively precise, simple and non-invasive method to rapidly diagnose these atelectasis.

A prospective observational study will be carried out including all patients undergoing scheduled laparoscopic surgery, excluding pregnant women or women in the period of lactation, patients with moderate - severe acute respiratory distress syndrome, heart failure, need for mechanical ventilation during the 15 days prior to surgery or with a history of cardiothoracic surgery. Demographic variables (age, sex, weight, BMI), preoperative data (presence of allergies, cardiovascular risk factors, personal cardiopulmonary history, presence of toxic habits, baseline peripheral oxygen saturation, ASA classification, ARISCAT and frailty markers will be collected - Fried phenotype, scale clinical frailty and FRAIL scale -) and intraoperative (duration of the procedure, parameters, recruitment maneuvers). At 30 postoperative days the history will be reviewed clinic of the patients and the postoperative complications will be collected. Main objective: to demonstrate the veracity of the air-test in the prevention of pulmonary or other systemic complications in patients undergoing laparoscopic surgery at the Doctor Negrín University Hospital of Gran Canaria.

Secondary objectives:

  • Measure the incidence of positive results in the air-test.
  • Demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test
  • Demonstrate the correlation between the degree of frailty of the patients and a positive score in the air-test.

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 undergoing scheduled laparoscopic surgery

排除标准

  • Pregnant or lactating women.
  • Presence of moderate to severe acute respiratory distress.
  • Patients suffering from heart failure.
  • Patients undergoing invasive mechanical ventilation during the 15 days prior to surgery.
  • Patients with a history of cardiothoracic surgery

结局指标

主要结局

Postoperative pulmonary complications

时间窗: 30 days postoperatively

to demonstrate the veracity of the air-test in the prevention of pulmonary complications in patients undergoing scheduled laparoscopic surgery

Postoperative systemic complications

时间窗: 30 days postoperatively

to demonstrate the veracity of the air-test in the prevention of systemic complications in patients undergoing scheduled laparoscopic surgery

次要结局

  • Recruitment maneuvers and air-test(from the intraoperative period (recruitment maneuvers) until 4 hours postoperatively)
  • Incidence of positive air-test(4 hours postoperatively)

研究者

发起方
Dr. Negrin University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ángel Becerra

Principal Investigator

Dr. Negrin University Hospital

研究点 (1)

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