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临床试验/NCT05432661
NCT05432661Unknown不适用

clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents usıng Endoscopic Retrograde Cholangiopancreatography Under sedatıon

Yunus Emre0 个研究点目标入组 120 人开始时间: 2022年6月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
Endotracheal intubation rate or complication

研究概览

简要总结

It is designed to monitor the efficacy of nasal cannula or hıgh-flow nasal oxygen in geriatric patients for endoscopıc retrograde cholangıopancreatography procedures. The aim of the study is to evaluate the efficacy and safety of oxygen support obtained with low-flow nasal cannula and hıgh-flow nasal oxygen during endoscopıc retrograde cholangıopancreatography in the patient group at risk for adverse respiratory events. We hypothesized that high-flow nasal oxygen administration can prevent adverse respiratory events such as deep sedation and patient position that may endanger the airway safety of patients, and reduce the problems in cardiac and hemodynamic parameters that may develop.

详细描述

In this retroprospective study, it was aimed to compare the effects of high flow nasal oxygen and standard nasal cannula use on hypoxia and oxygenation in geriatric endoscopic retrograde cholangiopancreatography cases performed under sedation in the prone position. Data belonging to the nasal cannula group will be obtained by scanning the forms and files retrospectively. Data in the high flow nasal oxygen group will be prospectively recorded during the procedure.

After the general anesthesia approval of the patients who will be applied ERCP, they are taken to the application room in the endoscopy unit. Here, standard monitoring (pulse oximetry, electrocardiography (ECG), non-invasive blood pressure measurement) is performed according to the criteria of the American Society of Anesthesiologists (ASA). in sedated patients for endoscopic retrograde cholangiopancreatography intervention, starting 5 minutes before sedation at 5-minute intervals; During the application, blood pressure, pulse, SpO2, presence of arrhythmia, interruptions due to airway interventions are monitored by the anesthesiologist and recorded in the case report form.

After the standard monitoring is established, preoxygenation is performed for 3 minutes. Then, 5 L/min of oxygen is given through the nasal cannula throughout the procedure. Patients who will receive oxygen support with high flow nasal oxygen (Inspired O2 FLO High Flow Oxygen Therapy) will be given 40 L/min oxygen with a high flow nasal oxygen system after preoxygenation. Patients will be followed for at least 15 minutes after the procedure or until the patient recovers.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

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

入选标准

  • Patients with physical condition class II-III of the American Society of Anesthesiologists, ----aged 65-90,
  • with Spo2 of 92% and/or below in room air,

排除标准

  • Coagulation disorder, nasopharyngeal obstruction,
  • bleeding tendency,
  • mental status disorder,
  • dementia,
  • cognitive impairment,
  • intubation,
  • tracheostomy,
  • need for oxygen therapy due to pre-existing disease,
  • patients on home oxygen or ventilator,
  • pregnancy,
  • recent history of epistaxis or allergy to propofol patients will be excluded.

结局指标

主要结局

Endotracheal intubation rate or complication

时间窗: 6 month

proportion of endotracheal intubation or complication

次要结局

  • Length of hospital stay(6 MONTH)

研究者

发起方
Yunus Emre
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yunus Emre

SPECIALIST DOCTOR

Ankara Training and Research Hospital

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