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临床试验/CTRI/2024/01/061007
CTRI/2024/01/061007尚未招募2 期

Comparision of the effect of high flow nasal cannula versus conevtional nasal cannula on oxygenation in patients undergoing Endoscopic Retrograde Cholangiopancreatography under sedation

Bangalore medical college and research institute1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年1月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
86
试验地点
1
主要终点
number of episodes of desaturation ,Spo2 90% during endoscopic retrograde cholangiopancreatography under sedation

研究概览

简要总结

ERCP (Endoscopic Retrograde Cholangiopancreatography) is a minimally invasive surgical procedure routinely used in the management of pancreatic and biliary disorders that require monitored anesthesia care to provide sedation and analgesia. ERCP is usually done in prone or lateral position which further complicates airway management.

Sedation can range from moderate to deep sedation, including General anesthesia.Intravenous sedation could depress the respiration, increase the risk of upper airway obstruction by relaxation of respiratory muscles, hypoxia and aspiration. Hypoxemia further increases periprocedural myocardial infarction,arrythmias and cerebral hypoxia.Usually, patients with complex co-morbidities:Obstructive sleep apnea syndrome, obesity, hypertension, DM, cardiac disorders, advanced age, high ASA physical status have increased risk of hypoxemia. Therefore, supplemental oxygen is provided to all patients undergoing ERCP using standard nasal cannula that can provide maximum up to 6L/min but the Fio2 is not more than 40% . The presence of the Endoscope precludes the use of face mask for delivering higher concentrations of oxygen. High flownasal oxygen is a new approach that provides heated and moist oxygen at a much higher gas flow rate (up to 70L/min), Fio2 up to 100%, provides flow dependent positive airway pressure to increase end expiratory lung volume, thus decreasing the work of breathing.

The HFNC is also used in perioperative setups including preoxygenation, airway management, awake intubation. However, use of HFNC has not been extensively studied in complex gastrointestinal procedures like ERCP.Thus, this study is intended to compare effect of high flow nasal cannula versus low flow nasal cannula on oxygenation in patients undergoing endoscopic retrograde cholangiopancreatography under sedation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to give informed written consent.
  • Patients belonging to American Society of Anesthesiologist class 1,2 and
  • Patients scheduled to undergo endoscopic retrograde cholangiopancreatography.

排除标准

  • Patients not willing to give informed written consent
  • Patients with anticipated difficult airway and known previous difficult intubation
  • Patients with severe cardiac disorders, respiratory disorders and renal disorders that necessitate general anesthesia with endotracheal tube
  • Patients with increased risk of aspiration
  • Patients undergoing emergency procedures
  • Tracheostomized patients.

结局指标

主要结局

number of episodes of desaturation ,Spo2 90% during endoscopic retrograde cholangiopancreatography under sedation

时间窗: 2 hours

次要结局

  • a)Number of events of hypoxia, defined as desaturation < 90%. The average number of events during the procedure will be compared between group A and B.(b)Lowest recorded SpO2% during the procedure. The mean values during the procedure will be compared between group A and B.)

研究者

发起方
Bangalore medical college and research institute
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rashmi N Patil

Bangalore Medical College and Research Institute

研究点 (1)

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