Perioperative Electrocardiogram Remote Monitoring to Assess Preoperative Psychological Distress and Improve Postoperative Recovery in Inflammatory Bowel Disease Surgery: a Pilot Single-arm Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV)
研究概览
简要总结
Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring.
详细描述
Inflammatory Bowel Disease (IBD) patients are at high risk of postoperative complications and delayed recovery. Preoperative anxiety and low patient's awareness of the disease may increase the risk of postoperative complications inducing an autonomic impairment which may in turn determine an inflammatory unbalance. This correlation can be confirmed through the preoperative monitoring of the autonomic function- with wearable electrocardiogram (ECG) devices. The Howdy Senior® device (ComfTech Srl) allows the real-time remote ECG monitoring and the computation of stress and fatigue indexes.
The Howdy Senior® device may also provide a reliable tool for remotely monitoring the patient's clinical parameters after discharge.
This study aims to explore the pathophysiological mechanisms linking preoperative anxiety and autonomic response and assess the feasibility and effectiveness of the Howdy Senior® device for the postoperative patients' remote monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients aged more than 18 years old.
- •Established Crohn's disease (CD) or Ulcerative Colitis (UC) at the time of surgery indication with a proven histological diagnosis.
- •Patients scheduled for elective intestinal resection.
排除标准
- •Diagnosis of Undetermined Colitis.
- •Recurrent disease.
- •Concomitant diagnosis of malignancy.
- •Established diagnosis of major depressive disorder or anxiety disorder.
- •Diagnosis of ventricular or supraventricular arrythmia.
- •Active pharmacological treatment with β-blockers or other drugs affecting the heart rate.
- •Known hypersensitivity to cotton or silver.
- •Emergent surgery.
- •Planned open surgery.
- •Any concomitant surgery unrelated to the main surgical indication. Patients undergoing perianal surgery for related perianal disease can be included in the study.
研究组 & 干预措施
Howdy Senior® device
Patients will undergo standard perioperative management. Additionally, patients will perform three preoperative and twelve postoperative HOWDY Senior® assessments. The assessment consists of a nocturnal electrocardiogram (ECG) measure and a morning rest Heart Rate Variability (HRV) measure of five minutes.
干预措施: Howdy Senior® device (Device)
Standard perioperative management
Patients belonging to the historical cohort of comparison, who underwent standard perioperative management and surgical intervention between January 2021 and January 2022.
结局指标
主要结局
Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV)
时间窗: From 14 days to 1 day before surgery
Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reporting scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the median value of at least three Heart Rate Variability (HRV) measures collected in the preoperative period through the Howdy Senior® device.
次要结局
- 90-day postoperative complications(90 days after surgery)
- Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI)(90 days after surgery)
- Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV)(90 days after surgery)
- Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S)(From 14 days to 1 day before surgery)
- Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery(24 hours after surgery)
- Healthcare costs(6 months after surgery)