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临床试验/NCT06040606
NCT06040606已完成不适用

Tangdu Hospital, Air Force Medical University

Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2023年2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
119
试验地点
1
主要终点
Postoperative Mortality

研究概览

简要总结

Postoperative complications and mortality in patients with COVID-19 Omicron infection who have undergone specialized thoracic surgery are scarce. Subsequently, the patient cohort was divided into two groups for comparative analysis: Group 1 (G1), which comprised patients who acquired nosocomial omicron infection after surgery, and Group 2 (G2), which comprised patients who remained uninfected with omicron during their hospitalization period. Propensity score matching (PSM) analysis was conducted using the PSMATCH function in SPSS 27 to assess the incidence of perioperative complications and mortality rates between both groups.

详细描述

Data of patients who underwent thoracic surgery at the Tangdu Hospital of Air Force Medical University and the Second Affiliated Hospital of Lanzhou University between December 1, 2022, and January 15, 2023, were collected. The data encompassed various clinical parameters, including age, sex, medical history, smoking history, disease classification, the extent of surgical resection, time of postoperative omicron diagnosis, duration of symptoms, COVID-19 classification (The symptoms of novel COVID-19 infection were classified as mild, medium, severe and critical according to the diagnosis and treatment of novel COVID-19 infection version 10), postoperative complications, and 30-day postoperative outcomes. Subsequently, the patient cohort was divided into two groups for comparative analysis: Group 1 (G1), which comprised patients who acquired nosocomial omicron infection after surgery, and Group 2 (G2), which comprised patients who remained uninfected with omicron during their hospitalization period. Hospital-acquired omicron infection was defined as having a positive reverse transcription polymerase chain reaction (RT-PCR) test for omicron from a nasopharyngeal or throat swab. Before admission, all the patients tested negative for omicron within 24 hours. In cases where patients presented with symptoms such as fever, daily RT-PCR testing was performed. A single positive result was considered sufficient evidence of infection.

According to the Clavien-Dindo classification, surgical complications are categorized as follows: Grade I encompasses medical interventions that deviate from the normal postoperative course but do not require drugs, surgery, endoscopy, or radiological intervention. Acceptable medical interventions may include the administration of antiemetics, antipyretics, analgesics, diuretics, electrolyte management, and physical therapy. This grade also includes superficial surgical site infections. Grade II involves complications that necessitate pharmacological treatment in addition to Grade I interventions, such as blood transfusions or total parenteral nutrition. Grade III involves complications that require surgical, endoscopic, or radiological interventions. Grade IV consists of life-threatening complications that require intermediate care or treatment in the intensive care unit. This grade includes central nervous system complications, such as cerebral hemorrhage, ischemic stroke, and subarachnoid hemorrhage, but excludes transient ischemic attacks. Finally, Grade V represents patient death.

The thoracic surgeries are classified as follows. Pulmonary surgery refers to the removal of lung tissue, irrespective of the extent of resection. Digestive system surgery encompasses procedures targeting diseases of the esophagus or gastroesophageal junction. The other surgery includes surgeries that do not involve the removal of lung tissue, addressing conditions affecting the chest wall, mediastinum, and other related areas.

Propensity score matching (PSM) analysis was conducted using the PSMATCH function in SPSS 27 to assess the incidence of perioperative complications and mortality rates between both groups. Considering these factors (age, sex, medical history, smoking history, disease classification, the extent of surgical resection), propensity matching was performed using a one-to-one nearest-neighbor matching algorithm with a match caliper standard deviation of 0.02. Each G1 patient was then paired with one G2 patient. Standardized mean differences were calculated to evaluate the balance between the matched groups, with differences exceeding 0.1 indicating potential imbalance. Categorical variables were described as frequencies and proportions and analyzed using the chi-square test to determine any statistical significance (P < 0.05). To confirm the factors contributing to the occurrence of complications, a logistic regression model was constructed, which incorporated confounding variables and examined their association with the occurrence of complications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Data of patients who underwent thoracic surgery at the Tangdu Hospital of Air Force Medical University and the Second Affiliated Hospital of Lanzhou University between December 1, 2022, and January 15, 2023, were collected.

排除标准

  • •Non-surgery patients.

结局指标

主要结局

Postoperative Mortality

时间窗: up to 1 months

Postoperative Mortality

Postoperative Complications

时间窗: up to 1 months

Postoperative Complications

次要结局

未报告次要终点

研究者

发起方
Tang-Du Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaolong Yan, Dr.

Deputy director

Tang-Du Hospital

研究点 (1)

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