Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Prevalence of sleep apnea
研究概览
简要总结
200 patients with colorectal cancer will be investigated before surgery and 100 of them after surgery.
Investigations will include polysomonographic sleep apnea recordings during one night, lung function measurements, blood gas samples and questionnaires.
Controls: Men and women from two population-based cohort studies
详细描述
Inclusion: 200 patients with colorectal cancer will be investigated before surgery and 100 of them will also be investigated in the same manner after surgery. Due to drop-outs we calculate a need of inviting at least 250 patients.
Exclusion: Dementia, CPAP treated sleep apnea investigations: Patients are investigated with lung function, blood-gas samples, questionnaires, overnight polysomnographic sleep apnea recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
Controls: Men and women from two population-based cohort studies the "Sleep and health in women" and the "Men in Uppsala: A Study of Sleep, Apnea and Cardiometabolic Health" and older men and women from a local senior organization.
Outcomes: Prevalence of sleep apnea and hypoxia, sleep quality, and lung function, blood gas, STOP-BANG, Epworth sleepiness scale, Mallampati score, symptoms of sleep apnea, surgical complications, mortality, cancer severity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for surgery of colorectal cancer
排除标准
- •Dementia, CPAP treatment for obstructive sleep apnea
结局指标
主要结局
Prevalence of sleep apnea
时间窗: 1 week
Apnea-hypopnea index
次要结局
- hypoxia, hypercapnia(1 week)
- subjective sleepiness(1 week)
- STOP-Bang(1 week)
- Sex differences(1 month)
- Sleep quality(1 week)
- lung function(1 week)
- Severity of cancer(30 days)
- Mortality(Until death)
- nocturnal hypoxia(1 week)
- Side effects of surgery(30 days)
- Mallampati score(1 day)
- Symptoms of sleep apnea(1 month)
研究者
Karl A Franklin
Assoc prof
Umeå University