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临床试验/NCT05737446
NCT05737446招募中不适用

Oxygen Partial Pressure After Breast Cancer Surgery

Umeå University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Oxygen partial pressure

研究概览

简要总结

Hypoxia and reduced oxygen partial pressure is commonly occurring after abdominal surgery. This study aims to investigate whether similar changes also occur after breast cancer surgery.

Inclusion: 60 women undergoing breast cancer surgery. Exclusion: Dementia or cognitive impairment that makes it impossible to participate in the study.

Arterial blood gas and lung function are undertaken before surgery and the day after surgery

详细描述

Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular risk for postoperative pulmonary complications including severe hypoxia are those who undergo abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung disease. The cause of postoperative hypoxia and reduced lung function is unknown. Previous studies report that arterial partial pressure (PaO2) decreased by an average of 2 kilopascal after abdominal surgery, while carbon dioxide partial pressure (PaCO2) was unchanged and vital capacity decreased by 35%. The effect of breast cancer surgery on oxygen and carbon dioxide partial pressure and lung function has to the best of the investigators knowledge not been investigated. This study aims to investigate possible changes in oxygen partial pressure, carbon-dioxide partial pressure and vital capacity after breast cancer surgery.

Design: Prospective cohort study participate in studies. Method: Blood gas measurements and Lung function (Vital capacity and FEV1) The day before surgery, the day after surgery and at follow-up.

Power analysis: There is a need to investigate 27 patients if the mean (SD) difference is 0.5 (1) kilopascal. Due to drop-outs the investigators calculate a need to include up to 60 patients.

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
Female
接受健康志愿者

入选标准

  • Women scheduled for surgery because of breast cancer.

排除标准

  • Dementia or cognitive impairment that makes it impossible to participate in the study.

结局指标

主要结局

Oxygen partial pressure

时间窗: 1 day

Change in oxygen partial pressure after surgery

次要结局

  • Carbon dioxide partial pressure(1 day)
  • Vital capacity(1 day)
  • Forced expiratory volume in 1 second (FEV1)(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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