Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 578
- 试验地点
- 2
- 主要终点
- Incidence of complications
研究概览
简要总结
This study aims to demonstrate that presurgical assessement of patients' risk factors and surveillance during surgery, both performed by nurses, are not inferior to anesthetic team's care, concerning the rate of complications in cataract surgery with topical anesthesia.
The nurse performs the triage of patients based on a chart of risk factors assessment. The triage, according to the presence or not of risk factors, leads to patients' care by an anesthetic team (medical anesthesist for pre-surgical assessement and anesthetic nurse for surveillance during surgery) or to patients' pre-surgical assessement and surveillance during surgery both performed only by nurses.
In the control group, all patients are taken care of by an aesthetic team, with medical pre surgical assessement and surveillance during surgery both performed by anesthetic nurses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •age > 18 years old
- •cataract surgery scheduled with topical anesthetics
- •outpatient surgery
排除标准
- •presurgical nurse assessment leading to the need for the anesthetic staff presence during surgery
- •general, peribulbar or other locoregional anesthesia required by patient's condition
- •concomitant surgery planified (glaucoma, vitrectomy...)
- •patient's refusal to participate in the study
- •no health insurance coverage
研究组 & 干预措施
nurses (intervention arm)
for patients without risk factors, the anesthetic team is not involved in patients' care
干预措施: nurses perform presurgical assessement and surveillance during surgery (Other)
anesthetic team (control arm)
the anesthetic team is involved in every patient's care (with or without risk factors)
干预措施: the anesthetic team performs presurgical assessement and surveillance during surgery (Other)
结局指标
主要结局
Incidence of complications
时间窗: through study completion, up to 6 months
complications occuring in operating theatre include systolic blood pressure \> 200 mmHg or \< 80 mmHg, diastolic blood pressure \> 110 mmHg, heart rate \< 45/mn for at least 1 mn, oxygen saturation (SpO2) \<90% for at least 1 mn, impossibility to start or to pursue surgery because of patient condition.
次要结局
未报告次要终点