Effects of the Application of a High-flow System Nasal Cannulas (Opti-Flow) Post General Anesthesia Versus Conventional Oxygen Therapy for Post-operative Hypoxemia After Gynecological Oncology Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- PaO2/FiO2 ratio
研究概览
简要总结
The primary aim of this study is to assess the efficacy of post-operatory HFNC in reducing the incidence of hypoxemia after gynecological oncology surgery, compared to the standard application of O2 through a Venturi mask; The secondary objectives are to investigate the occurrence and entity of lung atelectasis, to evaluate diaphragmatic function and respiratory discomfort, and to evaluate the incidence of respiratory complications after seven days in the two groups.
Patients will be randomized into two groups: HFNC and Control. The patients will be studied with preoperative lung and diaphragmatic ultrasound. Standard general anesthesia will be administered in the two groups. Ultrasound will be performed at arrival in the recovery room (RR) and before discharge from the RR. In the HFNC group, high-flow O2 will be administered; in the control group standard O2 therapy with Venturi mask will be administered.
Arterial blood gas analysis upon arrival in the RR and after two hours of O2 therapy in both groups will be checked.
The incidence of post-operative respiratory complications will be monitored in the seven days following surgery.
详细描述
Post-operative hypoxemia presents in 10-50% of patients undergoing surgery, and it is associated to unfavourable prognosis. Anesthesia-induced paralysis, the use of high oxygen concentrations (O2) and inadequate level of positive end expiratory pressure (PEEP), capnoperitoneum, Trendelenburg position, prolonged duration of surgery, contribute to pulmonary atelectasis, which are the principal cause of postoperative hypoxemia.
The use of high flow nasal cannulas (HFNC) has been recently studied in the treatment of hypoxemic patients in intensive care unit and in the immediate post-operatory period after abdominal and cardio-thoracic surgery. The role of post-operative HFNC in patients undergoing major gynecological oncology surgery has yet to be assessed.
Lung ultrasound is a safe and accurate bedside tool that allows to investigate pulmonary aeration and atelectasis developement. Diaphragmatic ultrasound is a recent bedside technique useful to assess diaphragm performance.
The principal aim of this study is to assess the efficacy of post-operatory HFNC in reducing the incidence of hypoxemia after gynecological oncology surgery, compared to the standard application of O2 through the Venturi mask. The secondary objectives are to investigate the occurrence and entity of lung atelectasis, to evaluate diaphragmatic function and respiratory discomfort, and to evaluate the incidence of respiratory complications after seven days in the two groups.
Study Design and Length:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for major gynecologic oncologic surgery (surgery duration > 2 hours).
排除标准
- •patient's refusal to participate to the study
- •pregnancy
- •mechanical ventilation in the 2 weeks before surgery
结局指标
主要结局
PaO2/FiO2 ratio
时间窗: At arrival in recovery room (10 min after extubation) and before discharge from recovery room (after 2 hours from arrival in recovery room).
Change in arterial Pa/FiO2 (in mmHg) in the two groups
次要结局
- PaO2/FiO2 ratio in hypoxemic patients(At arrival in recovery room (10 min after extubation) and before discharge from recovery room (after 2 hours from arrival in recovery room).)
- LUS score(Preoperative, upon arrival in recovery room (10 min after extubation) and before discharge from recovery room (after 2 hours from arrival in recovery room).)
- Thickening Fraction: Tei - Tee/Tee(Preoperative, upon arrival in recovery room (10 min after extubation) and before discharge from recovery room (after 2 hours from arrival in recovery room).)
- Respiratory discomfort(At arrival in recovery room (10 min after extubation) and before discharge from recovery room (after 2 hours from arrival in recovery room).)
- Postoperative Respiratory complications(At 7 days)