The Impact of Postoperative Opioids on Duration and Severity of Desaturation and Bradypnea in Opioid-naïve and Chronic Opioid Patients, Assessed by Continuous Vital Sign Monitoring.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 691
- 试验地点
- 2
- 主要终点
- SpO2 <88% in the four hours following opioid administration
研究概览
简要总结
Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients. Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Outcome: Respiratory deviations four hours after opioid administration
详细描述
Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients within the first four hours following opioid administration in addition to the chronic dose, using a continuously wireless monitoring system.
Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Continuous wireless monitoring data of peripheral tissue oxygenation (SpO2) and respiratory rate (RR) was conducted in postoperative patients. Data were stratified into opioid-naïve and chronic opioid patients, based on their preoperative opioid history. Patients who did not receive opioids postoperatively were served as the control group. Data was evaluated one hour before and four hours after opioid administration. The primary outcome was the cumulative duration of SpO2 <88%.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from studies WARD Surgery Observational [gov: NCT03491137]
- •The control group from WARD Surgery Randomized Controlled Trial [gov: NCT04640415]
排除标准
- •Less than 30 minutes of continuous monitoring data within the 60-minute window prior to opioid administration
- •Less than 120 minutes (<50% of theoretical maximum) of monitoring data available during the four-hour observation period
- •Patients who received transdermal fentanyl as postoperative opioid
- •Patients with a baseline saturation or respiratory rate below the prespecified thresholds
- •Patients with a BMI of ≥40 or diagnosed with COPD were excluded in the analysis of SpO2 <92%
结局指标
主要结局
SpO2 <88% in the four hours following opioid administration
时间窗: four hours following opioid administration
次要结局
- Respiratory deviations four hours after opioid administration(four hours following opioid administration)
研究者
Eske Kvanner Aasvang
Professor, head of research, MD, DmSci
Rigshospitalet, Denmark