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临床试验/NCT04663958
NCT04663958已完成不适用

Predictive Value of Ariscat Risk Index In The Development of Postoperative Pulmonary Complication After Major Abdominal Cancer Surgery

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 410 人开始时间: 2020年12月21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
410
试验地点
2
主要终点
Effectiveness of the ARISCAT risk scoring index

研究概览

简要总结

The term postoperative pulmonary complication is the development of any complications affecting the respiratory system after anesthetic and surgery procedures. The ARISCAT risk assessment score is a seven-variable regression model that divides patients into low, moderate, and high-risk groups. In this study, the investigators aimed to investigate the effectiveness of the ARISCAT risk scoring index in predicting postoperative pulmonary complication development in patients scheduled for major abdominal cancer surgery.

详细描述

Postoperative pulmonary complications (PPC) are one of the major causes of postoperative morbidity and mortality. Mortality and morbidity are 14-30% in patients with PPC, while it is 0.2-3% in patients without PPC. Its incidence is variable (<1% to 19%) and is more common than cardiac complications. Unfortunately, PPCs prolong the hospital stay significantly (up to 13-17 days), which means postoperative delirium, infection, and cost increase. The causes of PPCs are varied, and their physiopathology is well explained [3]. However, the rate of risk identification and scoring is not known. The synergistic effects of the patient's medical condition, general anesthesia, and surgery type on the respiratory system complicate the problem.The surgical approach, anesthesia method, and preoperative risk factors of the patients play an important role in the development of PPC.

This study was conducted after the approval from Dr. Abdurrahman Yurtaslan Oncology SUAM Ethics Committee in Ankara, Turkey (Between December 2020 - July 2021) (Ethics Committee Decision No: 2019-11 / 459). After informing all the patients included in the study, verbal and written consent were obtained. 410 patients over 18 years of age, who were scheduled for general anesthesia and whose ASA physical score was 1-4, were included in the study.

Demographic data of the patients, preoperative antibiotic prophylaxis, chronic diseases, ASA scores, preoperative hemoglobulin values, functional status, history of pulmonary system disease in the last 30 days, history of smoking and the amount of cigarette consumption, history of steroid use, chemotherapy and radiotherapy history, anesthesia method, surgical incision side (lower-upper abdominal), premedication status, intraoperative ventilation parameters (tidal volume, PEEP, peak pressure, fiO2 ratio), pneumoperitoneum pressure, amount of colloid / crystalloid product used, erythrocyte suspension and amount used, laparoscopic or open surgery, emergency or elective surgery, the duration of operation, and postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) were recorded. The ARISCAT risk assessment scores of the patients were also evaluated and recorded preoperatively.

The patients were followed up in the postoperative care unit. The presence of postoperative pulmonary complications was evaluated, and the time of discharge was recorded. On the 30th day after discharge, patients were called and checked their status in terms of mortality. Postoperative pulmonary complications were defined by the development of one of the following new findings. The European Perioperative Clinical Outcome Definitions (EPCO) were used for this definition.

These findings; Respiratory Failure, Respiratory infection, Aspiration Pneumonia, Pleural effusion, Pneumothorax, Atelectasis, Bronchoconstriction, Pneumonia, ARDS, Pulmonary Embolism, Pulmonary Edema, Unplanned emergency re-intubation, Leaving as intubated from the operation room.

研究设计

研究类型
Observational
观察模型
Other
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

  • Over 18 years of age
  • Who were scheduled for general anesthesia
  • Whose ASA physical score was 1-4

排除标准

  • ASA physical status> 4
  • Pregnant women
  • Intubated patients before the operation
  • Patients who had surgery due to a previous surgical complication
  • Severe cardiovascular disease
  • Severe hemodynamic instability

结局指标

主要结局

Effectiveness of the ARISCAT risk scoring index

时间窗: postoperative first 7 days

to investigate the effectiveness of the ARISCAT risk scoring index in predicting the development of PPC in patients undergoing major abdominal cancer surgery

次要结局

  • Correlation between BMI (kg/m^2) and PPC(postoperative first 30 days)
  • Correlation between age (years) and PPC(postoperative first 30 days)
  • Correlation between history of smoking and the amount of cigarette consumption level (packs/year) and PPC(postoperative first 30 days)
  • Correlation between ASA physical score (1-4) and PPC(postoperative first 30 days)
  • Correlation between surgical incision side (lower-upper abdominal) and PPC(postoperative first 30 days)
  • Correlation between the duration of operation (<2 hours, 2-3 hours, more than 3 hours) and PPC(postoperative first 30 days)
  • Correlation between gender(male or female) and PPC(postoperative first 30 days)
  • Correlation between Preoperative Sp02(>96%, 91%-95%, <90%) and PPC(postoperative first 30 days)
  • Correlation between preoperative hemoglobulin values (gram / deciliter) and PPC(postoperative first 30 days)
  • Correlation between laparoscopic or open surgery and PPC(postoperative first 30 days)
  • Correlation between , emergency or elective surgery and PPC(postoperative first 30 days)
  • Correlation between postoperative analgesia method (such as intravenous or epidural patient-controlled analgesia) and PPC(postoperative first 30 days)

研究者

发起方
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Kemal ŞAHİN

Principal Investigator

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

研究点 (2)

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