Shao Liu-Jia-Zi, Liu Shao-Hua, Liu Fu-Kun, Zou Yi, Hou Hai-Jun, Tian Ming, Xue Fu-Shan
Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong-An Road, Xi-Cheng District, Beijing, 100050, People's Republic of China.
Trials. 2018 Nov 1;19(1):602. doi: 10.1186/s13063-018-2994-8.
Hypoxemia is a major complication in obese patients undergoing gastrointestinal endoscopy under intravenous anesthesia or sedation due to altered airway anatomy. We design this randomized controlled trial (RCT) to compare efficacy and safety of the Wei nasal jet tube (WNJT) and nasal prongs for supplement oxygen during gastroscopy with intravenous propofol anesthesia in obese patients.
The study will be a single-center, prospective RCT. A total of 308 obese patients will be recruited and randomly assigned to receive either the WNJT (group A) or nasal prongs (group B). During gastroscopy with intravenous propofol anesthesia, 5 L/min of oxygen will be delivered through the jet port of the WNJT in the group A and via the nasal prongs in the group B. The primary outcome is the incidence of hypoxemia and severe hypoxemia. The secondary outcomes are adverse events during the gastroscopy, postoperative complications, and satisfaction of the anesthetist, physician, and patient.
This RCT aims to clarify whether the WNJT can result in reduced incidences of hypoxemia and complications and provide improved satisfaction to the anesthetist, physician, and patient. Thus, it can be determined if the WNJT is a useful tool for supplement oxygen in obese patients undergoing gastroscopy with intravenous propofol anesthesia. The results will provide the evidence for anesthesiologists to make a decision regarding the choice of supplementary oxygen methods in this condition.
Chinese Clinical Trial, ChiCTR-IOR-17013089 . Registered on 23 October 2017.
由于气道解剖结构改变,低氧血症是肥胖患者在静脉麻醉或镇静下接受胃肠内镜检查时的主要并发症。我们设计了这项随机对照试验(RCT),以比较在肥胖患者静脉注射丙泊酚麻醉下进行胃镜检查时,伟氏鼻喷管(WNJT)和鼻导管吸氧的有效性和安全性。
本研究将是一项单中心、前瞻性RCT。共招募308例肥胖患者,随机分为伟氏鼻喷管组(A组)或鼻导管组(B组)。在静脉注射丙泊酚麻醉下进行胃镜检查时,A组通过伟氏鼻喷管的喷射口以5升/分钟的流量输送氧气,B组通过鼻导管输送氧气。主要结局是低氧血症和严重低氧血症的发生率。次要结局是胃镜检查期间的不良事件、术后并发症以及麻醉医生、内科医生和患者的满意度。
这项RCT旨在阐明伟氏鼻喷管是否能降低低氧血症和并发症的发生率,并提高麻醉医生、内科医生和患者的满意度。因此,可以确定伟氏鼻喷管是否是肥胖患者在静脉注射丙泊酚麻醉下进行胃镜检查时补充氧气的有用工具。研究结果将为麻醉医生在这种情况下选择补充氧气方法提供决策依据。
中国临床试验,ChiCTR-IOR-17013089。于2017年10月23日注册。