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手部测力计测量、PFT 和 mFI 与术后结果之间的关系

肺切除患者术前手测力计测量、肺功能测试和改良衰弱指数与术后结果的关系

The study will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital and will include 100 patients over the age of 40 who are scheduled for lung malignancy surgery after 01 April 2024. Informed consent will be obtained from all patients, who will be assigned a number from 1 to 100.

For patients over 40 years of age who are scheduled to undergo lung malignancy resection surgery, demographic data including age, gender, height, weight, body mass index (BMI), diagnosis, comorbidities, and ASA (American Society of Anaesthesiologist) score will be recorded. In addition, hand grip strength measurement, pulmonary function test, and modified frailty index (a scoring system that includes 11 parameters) will be recorded prior to surgery. Intraoperative and postoperative complications will be documented. The duration of the patient's stay in the intensive care unit, chest tube removal, length of hospital stay, and postoperative complications will also be recorded. A follow-up call will be made to the patient by the responsible researcher 90 days after the operation to inquire about any complications that may have developed within that time frame.

The study aims to investigate the relationship between preoperative hand grip strength measurement, pulmonary function test analysis (PFT), and modified frailty index with the duration of intensive care unit stay, chest tube withdrawal time, hospital stay, and postoperative complications in patients undergoing lung resection due to malignancy.

研究概览

研究类型

观察性的

注册 (实际的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Keçiören
      • Ankara、Keçiören、土耳其(türkiye)、06290
        • Ankara Atatürk Sanatorium Training and Research Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

During a 3-month period, we calculated that we needed 91 patients to achieve a 95% confidence level with a margin of error of ±5%. This calculation was based on the assumption that 40% of all surgical patients in our clinic had malignant lung resection. We selected a sample size of 100, taking into account possible non-study factors.

描述

Inclusion Criteria:

  • All patients over the age of 40 who will undergo lung resection due to malignancy

Exclusion Criteria:

  • Patients undergoing emergency surgery
  • Patients with missing preoperative measurements
  • Patients with missing 90-day follow-up data

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:OTHER
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Complications (No)

Patients who did not experience any postoperative complications within 90 days.

Hand grip strength will be measured using a hand dynamometer. Research has demonstrated that hand grip strength is correlated with muscle strength in the upper extremities, as well as overall body and pulmonary muscle strength.

Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time. Spirometry is a diagnostic test of several common respiratory disperses such as asthma and chronic obstructive pulmonary disease (COPD). It is also instrumental in monitoring the progression of various respiratory disorders. The main results of spirometry are forced vital capacity (FVC), forced expiratory volume exhaled in the first second (FEV1), and the FEV1/FVC ratio. Pulmonary Function Test analysis values (FEV1, FVC and FEV1 /FVC) will be used.

其他名称:
  • 肺量计

The modified frailty index is a valuable preoperative risk assessment tool that can be used to assess the risk of both morbidity and mortality in patients undergoing surgery. It is calculated based on 11 parameters.

Complications (Yes)

Patients who experienced any complications within 90 days after surgery.

Hand grip strength will be measured using a hand dynamometer. Research has demonstrated that hand grip strength is correlated with muscle strength in the upper extremities, as well as overall body and pulmonary muscle strength.

Spirometry is a physiological test that measures the ability to inhale and exhale air relative to time. Spirometry is a diagnostic test of several common respiratory disperses such as asthma and chronic obstructive pulmonary disease (COPD). It is also instrumental in monitoring the progression of various respiratory disorders. The main results of spirometry are forced vital capacity (FVC), forced expiratory volume exhaled in the first second (FEV1), and the FEV1/FVC ratio. Pulmonary Function Test analysis values (FEV1, FVC and FEV1 /FVC) will be used.

其他名称:
  • 肺量计

The modified frailty index is a valuable preoperative risk assessment tool that can be used to assess the risk of both morbidity and mortality in patients undergoing surgery. It is calculated based on 11 parameters.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Complication
大体时间:90 days

Complication data for patients who underwent lung resection for malignancy during the 90-day follow-up period.

90 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gülay ÜLGER, specialist、Ankara Ataturk Sanatorium Training and Research Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年5月1日

初级完成 (实际的)

2024年10月30日

研究完成 (实际的)

2024年10月30日

研究注册日期

首次提交

2024年3月24日

首先提交符合 QC 标准的

2024年3月24日

首次发布 (实际的)

2024年3月29日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2024年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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