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临床试验/NCT06482879
NCT06482879已完成不适用

Comparison of Hypoxia Between High Flow Nasal Canula and Simple Nasal Canula in Patient Undergoing Upper Gastrointestinal Endoscopic Procedures in Deep Sedation

National Academy of Medical Sciences, Nepal1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
122
试验地点
1
主要终点
Comparison of incidence of hypoxia between high flow nasal canula and Simple nasal canula

研究概览

简要总结

Hypoxia frequently occurs as a complication during upper gastrointestinal endoscopic procedures performed under deep sedation. Traditional oxygen delivery methods, such as the simple nasal cannula, are commonly used to prevent hypoxia in these cases. The high-flow nasal cannula, capable of delivering FiO2 levels of up to 1 and flow rates of up to 70 l/min, offers additional benefits, including positive end-expiratory pressure and reduced dead space. We hypothesized is that the use of high-flow nasal cannula can decrease the incidence of hypoxia in comparison to simple nasal cannula in patients undergoing upper gastrointestinal endoscopic procedures under deep sedation.

This was prospective, comparative observational study conducted in a tertiary care center of Nepal with the primary objective to compare the rates of hypoxia (SpO2 < 92%) and secondary objectives were to compare interruption of procedure due to hypoxia, minimum hypoxia level and episodes of hypoxia between high flow nasal canula (flow rate of 30l/min with FiO2 of 0.5) and simple nasal canula (flow rate of 6l/min) in patients undergoing upper gastrointestinal endoscopic procedures in semi-prone position in deep sedation using propofol infusion.

The study comprised 125 participants, 58 in simple nasal canula and 67 in high flow nasal cannula group. The incidence of hypoxia in simple nasal cannula and high flow nasal cannula groups, with rates of 37.3% (22/58) and 16.4% (11/67), respectively. The relative risk (RR) of hypoxia was 0.43 (95% CI: 0.23-0.81), with a p-value of 0.009. Procedural interruptions due to hypoxia occurred in 8.6% (5/58) of participants in the simple nasal cannula group and 4.47% (3/67) in the high flow nasal cannula group, with RR of 0.17 (95% CI: 0.02-1.41) and a p-value 0.1. Furthermore, the occurrence of multiple episodes of hypoxia was higher in the simple nasal cannula group compared to the high flow nasal cannula group (5 vs. 0), with a p-value < 0.001.The use of high flow nasal cannula reduces the occurrence of hypoxia in patients undergoing upper gastrointestinal endoscopic procedures with deep sedation compared to simple nasal cannula.

详细描述

This study was prospective, comparative, open-label and observational study conducted on tertiary hospital of Nepal between July 2023-April 2024.A written informed consent was taken from all the patients before enrolling to study. Patient aged more than 16 years, ASA-PS grading I-IV, both the gender, both elective procedures undergoing complex UGI endoscopic procedure in deep sedation under propofol infusion were included. Patient not willing to enrolled, pre-operative SPO2 < 92% and pre-operative MAP < 60 mm Hg were excluded from study. Sixty-two patients were enrolled in each group so total sample size was 124 using following sample size formula. .

After arriving in the procedure room, standard monitoring, including pulse oximetry, non-invasive blood pressure monitoring, and electrocardiography were attached. An anesthesiologist assigned made the decision on which oxygenation device to use for the patient. In SNC group, an oxygen flow rate of 6 l/min where in HFNC group at the beginning of procedure flow was set 10 l/min once patient was induced flow rate increased to 30 l/min with FiO2 of 0.5. The patients were positioned either laterally or semiprone. Prior to the start of the procedure, the patient was given an injection of fentanyl 1mcg/kg. An initial dose of propofol was administered at a rate of 1-1.5 mg/kg by slow titrating manner. The sedation level, ventilatory pattern,rate and depth were clinically monitored throughout the procedure.The propofol infusion was kept between 25-150 mcg/kg/min, aiming for preventing facial grimace, agitation, or gag reflex, while still allowing the patient to respond to painful stimuli. In case of any sings of agitation noticed, the anaesthesiologist added the additional dose of propofol or increase the propofol infusion rate or both, as in our usual practice.

In SNC group, if SpO2 decreased below 92%, flow rate increased to 8 l/min whereas in HFNC group FiO2 increased to 1 and flow rate increased to 50 l/min. If desaturation continued despite of above mentioned measure in both groups, anesthesiologist increased the FiO2, flow or both. Bag mask ventilation and tracheal intubation was done if needed. Other events; bradycardia needing atropine, hypotension needing vasopressor, persistent hypoxia needing bag and mask, endotracheal intubation was recorded.

Hypoxia is defined as a decrease in oxygen saturation < 92%. Severe hypoxia is defined as a decrease in oxygen saturation < 80%. Primary outcome was the compare the rate of hypoxia and secondary outcome was to compare the rate of interruption of procedure due to hypoxia and episodes of hypoxia during the procedure between the two groups.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged more than 16 years ASA-PS grading I-IV, Both gender -

排除标准

  • Patient not willing to enrolled, Pre-operative SPO2 < 92%, Pre-operative MAP < 60 mm Hg, Emergency procedure

结局指标

主要结局

Comparison of incidence of hypoxia between high flow nasal canula and Simple nasal canula

时间窗: During the procedure

次要结局

  • Comparison of interruption of procedure between high flow nasal canula and Simple nasal canula(During the procedure)
  • Comparison of frequency of hypoxia between high flow nasal canula and Simple nasal canula(During the procedure)

研究者

发起方
National Academy of Medical Sciences, Nepal
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anuj Jung Karki

Associate professor

National Academy of Medical Sciences, Nepal

研究点 (1)

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