The Effects of Pre-extubation Single Recruitment Maneuver on Lung Ultrasound Scores and Postoperative Oxygenation in Laparoscopic Nephrectomy Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comparison of the pre-extubation LUS scores (T3)
研究概览
简要总结
Laparoscopic surgeries may cause atelectasis on the lungs which may stay clinically occult after the surgery. Lung Ultrasound Scoring (LUS) can provide an objective measuring system to understand the condition of the lungs in the perioperative period. In this randomized controlled study, it is aimed to investigate the effects of one single recruitment maneuver (RM) just before emergence and extubation (at the end of surgery) on LUS scores and postoperative recovery room oxygenation in laparoscopic nephrectomy surgeries. Accordingly, the intervention group will be applied single RM before extubation, while the control group will be awaken without RM.
There will be LUS evaluation at 4 different time for intervention group (Group RM) points that are:
T1: 5 min after the intubation T2: At the end of surgery (After skin closure, before recruitment maneuver) T3(RM): After recruitment maneuver, before extubation T4: 30 minutes after extubation in the recovery room
LUS evaluation will be made at 3 different time points in control group (Group NoRM):
T1: 5 min after the intubation T3(NoRM): Before extubation (no recruitment maneuvers will be made) T4: 30 minutes after extubation in the recovery room.
The primary outcome is the comparison of the T3 LUS scores. Assuming a 40% difference in the T3 LUS score, total number of 30 patients were calculated to be included in the study with an alpha value of 0.05 and 95% power. A possible drop-out of 5 patients per group, 20 patients were planned to be enrolled in each group.
Secondary outcomes will include; difference in T4 LUS scores, the effect of RM on postoperative recovery room oxygenation, and the effect of deltaLUS (T3-T2) on postoperative recovery room oxygenation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •Laporoscopic nephrectomy patients who will be operated in lateral positions
- •Elective, semi-elective surgeries
排除标准
- •Patients with emphysema
- •Patients with documanted heart failure
- •Patients requiring intraoperative multiple recruitment maneuver due to hypoxemia
- •Patients with hemodynamic instability
- •Patients with pneumothorax risk
- •Emergency surgery
- •Patients requiring intraoperative liberal fluid therapy (>10 cc/kg/hr)
- •Patients requiring blood products
结局指标
主要结局
Comparison of the pre-extubation LUS scores (T3)
时间窗: Up to 4 hours
Lung ultrasound will be applied in each group to observe the lungs' condition (atelectasis,consolidation...) and understand the effect of a "single" recruitment maneuver. To obtain LUS score; each lobe is examined on 6 different areas which will be scored from 0 to 3, and both lungs will be evaluated. Therefore maximum score may change from 0 (no atelectasis, best condition) to 36 (worst condition, broad atelectasis and consolidation).
次要结局
- The effect of deltaLUS (T3-T2) on oxygenation(Up to 4.5 hours)
- Length of stay in post anesthesia care unit (PACU)(Up to 4 hours)
- Length of stay in hospital(Up to 2 weeks)
- Predictive value of dependant lung T3 (preextubation) LUS score detecting postoperative pulmonary complications(Up to 24 hours)
- Comparison of recovery room PaO2(Up to 4.5 hours)
- Postoperative respiratory complications(Up to 5 days)
- Comparison of recovery room LUS scores (T4)(Up to 4.5 hours)
研究者
Emre Sertaç Bingül
Principal investigator, Lecturer, Medical Doctor
Istanbul University