Dynamic Prediction of First-Night Sleep Protection Needs After Thoracoscopic Lobectomy/Segmentectomy and Analysis of the Impact of Ward Routines
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Clinically significant postoperative sleep disturbance on the first night after VATS lobectomy or segmentectomy
研究概览
简要总结
This study combines retrospective data analysis with a single-center prospective non-interventional cohort study to understand postoperative sleep disturbance on the first night after video-assisted thoracoscopic (VATS) lobectomy or segmentectomy. It mainly wants to answer the question: Can perioperative data collected along the clinical timeline dynamically predict which patients will experience clinically significant sleep disturbance on their first postoperative night? Participants undergoing elective VATS lung resection will have multidimensional data systematically collected from preoperative screening (including PSQI and GAD-7), intraoperative anesthetic parameters, PACU-to-ward handover, pre-bedtime symptom burden, and follow-up through 1 month. Three dynamic prediction models (M0 preoperative screening, M1 early postoperative update, and M2 pre-bedtime main model) will be developed using logistic regression with RCSQ-assessed sleep disturbance as the primary outcome, while an explanatory model will quantify the impact of nighttime disruptions such as intravenous infusions, vital sign monitoring, nursing entries, and awakenings.
详细描述
This study combines retrospective data analysis with a single-center prospective non-interventional cohort study. The primary data collection is prospective, while retrospective data may be used for preliminary analysis or baseline comparison.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Aged 18 years or older; Scheduled for elective video-assisted thoracoscopic surgery (VATS) lobectomy or segmentectomy; Planned postoperative admission to a general thoracic surgery ward; American Society of Anesthesiologists (ASA) physical status classification I-III; Capable of understanding questionnaires and verbal communication; Prospective cohort participants who voluntarily enroll in the study and provide written informed consent.
排除标准
- •Emergency or trauma-related surgery; Planned direct postoperative admission to the intensive care unit (ICU); Severe cognitive impairment, delirium, or acute phase of psychiatric disorders; Severe hearing, speech or visual impairment precluding completion of assessments; Confirmed pregnancy or breastfeeding status; Chronic long-term use of sedative-hypnotics with unassessable baseline sleep status; Subjects deemed unlikely to complete key data collection or follow-up at the investigator's discretion.
结局指标
主要结局
Clinically significant postoperative sleep disturbance on the first night after VATS lobectomy or segmentectomy
时间窗: From PACU return to the general thoracic ward until 06:00 on postoperative day 1, assessed on the morning of postoperative day 1
Clinically significant postoperative sleep disturbance (PSD) assessed by the Richards-Campbell Sleep Questionnaire (RCSQ) on postoperative day 1 morning. RCSQ contains 5 items (sleep depth, latency, awakenings, return to sleep, overall quality) scored 0-100; total score is the mean (higher=better). PSD defined as RCSQ total ≤50. First postoperative night: from PACU return to 06:00 next day (or actual return time if after 22:00). One missing item: mean of remaining four; ≥2 missing or inability to complete due to delirium/cognitive/communication barriers: invalid.
次要结局
未报告次要终点