High Flow Oxygen During ProcEdural Sedation for Operative Hysteroscopy: a Randomized Controlled Trial - HOPE Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Rate of success of ventilation with THRIVE.
研究概览
简要总结
High-flow nasal cannula (HFNC) oxygen therapy represents an open circuit ventilation system that uses flows up to 70 L/min of 100% oxygen through the Optiflow THRIVETM device (Fisher and Paykel Healthcare Ltd, Auckland, New Zealand). Compared to conventional oxygen therapy systems, the heating and humidification of the flows facilitate tolerability by the patient, allow to reach higher and more stable inspiratory fractions of oxygen, produce a flow-dependent effect of continuous positive airway pressure and by reducing dead space, have the potential to increase alveolar volume and improve gas exchanges.
The use of HFNC is increased in anesthesia as the only airways management technique during short-term procedures under procedural sedation or general anesthesia.
Operative hysteroscopy is a short-term procedure (<30 minutes), usually performed in a day-hospital regimen, under procedural sedation. In case of apnea and/or hypoventilation, or for long and complex hysteroscopic procedures, the patient can be ventilated through facial or laryngeal masks.
The primary objective of this prospective randomized controlled trial is to compare the rate of success of ventilation using the THRIVE device to laryngeal mask ventilation during operative hysteroscopies under procedural sedation.
Secondary objectives will be the comparison of the percentage of complications in terms of inability to manage the airways, episodes of hypotension, cardiac arrhythmias, post-operative nausea and vomiting, degree of dyspnea and comfort of the patient in the Post-Anesthesia Care Unit between the two methods.
详细描述
High-flow nasal cannula (HFNC) oxygen therapy represents an open circuit ventilation system that uses flows up to 70 L/min of 100% oxygen through Optiflow THRIVETM (transnasal humidified rapid-insufflation ventilatory exchange) device (Fisher and Paykel Healthcare Ltd, Auckland, New Zealand).
Compared to conventional low-flows oxygen therapy systems, the heating and humidification of the flow facilitate tolerability by the patient, ensure an efficient muco-ciliary function and allow to reach higher and more stable inspiratory fractions of oxygen.
The system produces a flow-dependent effect of continuous positive airway pressure of about 1 cmH20 for every 10L/min increase in oxygen flow and a reduction of the dead space, having the potential to increase the alveolar volume thus improving gas exchanges.
The resulting reduction in respiratory rate and the improvement of thoracoabdominal synchrony minimize the onset of respiratory fatigue in the patient.
Initially introduced for the treatment of acute hypoxemic respiratory failure, HFNC oxygen therapy is increasingly used also in anesthesia as the only airways management technique during short-term procedures performed under sedation (e.g. digestive endoscopy) or under general anesthesia (such as microlaryngoscopies).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing operative hysteroscopy
- •ASA I-II.
排除标准
- •BMI > 30,
- •pregnancy,
- •cardiac arrhythmia,
- •high risk of aspiration,
- •neuromuscular disease,
- •patient refusal.
结局指标
主要结局
Rate of success of ventilation with THRIVE.
时间窗: Throughout the surgical procedure
Comparison of the rate of success in airways management with the THRIVE system versus positive pressure ventilation by laryngeal mask. The failure of the method will be defined as a CO2 value measured by transcutaneous monitor (Radiometer) \> 65 mmHg AND/OR a peripheral O2 saturation measured by pulse oximeter \< 94%.
次要结局
- Postoperative complications - 2(At the end of the surgery.)
- Airway related complications.(At the end of the surgery.)
- Postoperative complications - 3(At the end of the surgery.)
- Postoperative complications - 1(At the end of the surgery.)