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临床试验/NCT07118917
NCT07118917已完成不适用

Does a Prior COVID-19 Infection Affect Lung Dynamics During Thoracic Anesthesia?

Ankara University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年9月12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
110
试验地点
1
主要终点
Mechanical Power Calculation

研究概览

简要总结

SARS-CoV-2 has infected more than 776 million people worldwide, raising concerns about its impact on patients with lung cancer, the most common cancer in men and the second most common cancer in women. Previous studies have suggested that COVID-19 may worsen lung dysfunction in patients undergoing surgery and that the coexistence of COVID-19 and lung cancer increases the risk of complications and mortality. It has been recommended that surgery be delayed after COVID-19 infection to reduce postoperative risk. This study examined the effects of prior COVID-19 infection on respiratory mechanics in patients undergoing thoracic surgery for lung cancer.

详细描述

COVID-19 positivity was confirmed in 53 patients via SARS-CoV-2 RT-Prowhite, and the remaining 57 patients were classified as COVID-19 negative on the basis of a lack of prior positive PCR tests and the absence of COVID-19 symptoms in medical records. Statistical analysis was performed via SPSS Statistics for Windows, Version 17.0 (Chicago: SPSS Inc.). The Shapiro-Wilk test was used to assess the normality of the data distribution, a standard approach to determine the appropriateness of parametric versus nonparametric tests. For variables that did not follow a normal distribution, the Mann-Whitney U test was applied because of its suitability for comparing two independent groups with nonparametric data. For normally distributed variables, Student's t test was used to compare means between the COVID-19-positive and COVID-19-negative groups. Logistic regression was employed to evaluate the association between waiting time intervals (as a continuous predictor) and postoperative pulmonary complications (a binary outcome), given its robustness for such analyses. Categorical data, such as operation types and comorbidities, were compared via the chi-square test or Fisher's exact test when expected cell counts were low, ensuring statistical validity. A p value <0.05 was considered to indicate statistical significance. Compared with experimental models such as D'Albo et al.[21] (n = 82), which effectively identified significant effects of mechanical power, our sample size of 110 patients was adequate to detect differences in lung dynamics. Patients were monitored with a bispectral index (BIS) (Covidien, Boulder, CO, USA) and Train-of-Four (TOF) (GE HealthCare, Chicago, Illinois, USA) in addition to the monitoring recommended by the American Society of Anesthesiologist (ASA). Patients were given IV access with a 22G branch contralateral to the side to be operated on. After preoxygenation with 80% FiO2, anesthesia was induced with 1 mg/kg lidocaine and 1.5 mcg/kg fentanyl followed by propofol under BIS guidance, and 1.2 mg/kg rocuronium was administered after the reference value for TOF was taken. After TOF 0 was observed, patients were intubated with a double lumen tube with a Macintosh blade. The size of the tube was determined to be 35-37 Fr for women and 39-41 Fr for men. The placement of the tube was confirmed via bronchoscopy. Patients were placed in the lateral decubitus position after fixation. After the position was completed, the placement of the tube was confirmed again via bronchoscopy. The mechanical ventilator settings were determined to be 7 ml/kg according to the ideal weight for both lungs and 5 ml/kg for single-lung ventilation. The PEEP (positive end-expiration pressure) was set as 5 cm H2O for all of the patients. FiO2 was titrated to a SpO2 >92. Mechanical power (MP) was calculated via the simplified formula of Gattinoni et al.: MP = 0.098 × RR × VT × (Ppeak - Pplat/2), where RR is the respiratory rate, VT is the tidal volume, Ppeak is the peak pressure, and Pplat is the plateau pressure. This measures the energy delivered to the lungs during ventilation, expressed in joules/minute.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • age ≥18 years and planned procedures, including pneumonectomy, lobectomy, segmentectomy, or other lung resections

排除标准

  • patient refusal to participate and inability to provide informed consent due to psychological or mental incapacity.

结局指标

主要结局

Mechanical Power Calculation

时间窗: Intraoperative period ( Day of Surgery)

次要结局

  • Plato Pressure(Intraoperative period ( Day of Surgery))

研究者

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

CIGDEM YILDIRIM GUCLU

Professor

Ankara University

研究点 (1)

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