JPRN-jRCTs042220151招募中2 期
Single-center, single-arm pilot study of the feasibility of measuring oxygen saturation with a tissue oxygen saturation monitor in pharyngeal suture and permanent tracheal stoma in total laryngectomy
Mukaigawa Takashi0 个研究点目标入组 20 人开始时间: 2023年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients scheduled for palliative or radical surgery for total laryngectomy*
- •2. If due to cancer, the primary site is irrelevant
- •3. If due to cancer, any tissue type
- •4. Patients who gave written informed consent before enrollment
- •5. Aged 18 or older at the time of obtaining consent
- •* Including total laryngectomy to prevent aspiration due to severe aspiration
排除标准
- •1. Patients who cannot be closed with pharyngeal mucosal suture alone and will require a free flap
- •2.Uncontrolled diabetes mellitus
- •3. Unstable angina pectoris (angina pectoris with onset or exacerbation within the last 3 weeks) or history of myocardial infarction within 6 months.
- •4.Poorly controlled hypertension as a complication.
- •5.Receiving continuous systemic (oral or intravenous) steroids or other immunosuppressants
- •6. SPO2<90% at enrollment
- •7. Severe occlusive vasculopathy
- •8. Complications with other cancers requiring simultaneous surgery
- •9.In addition, patients who are considered inappropriate as subjects of this study by the judgment of the doctor
研究者
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