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临床试验/NCT05137574
NCT05137574已完成不适用

Importance of Integrated Pulmonary Index in Pediatric Patients Undergoing Endoscopy Procedures Under Sedation

Marmara University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
IPI-Ketamine

研究概览

简要总结

Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2). It is a valuable monitor for sedation procedures and can provide early warning during cardiorespiratory derangements. In this study, we wanted to evaluate the value of IPI in cases of pediatric endoscopy performed under sedation. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.

详细描述

Upper gastrointestinal system (GIS) endoscopy is a common diagnostic or interventional procedure in cases such as foreign body ingestion, gastritis, peptic ulcer, esophagitis, esophageal variceal bleeding. Lower GIS endoscopy is a procedure performed in cases such as Crohn's or Ulcerative Colitis diseases, colon polyps, diverticular disease. It is routinely performed under general anesthesia or sedation in pediatric cases. In our clinic, we routinely perform diagnostic or interventional pediatric upper and lower endoscopy procedures with the non-operating room anesthesia team under monitored anesthetic care (MAC). Routine monitoring of MAC consists of electrocardiography (ECG), non-invasive blood pressure (NIBP), and peripheral oxygen saturation (SpO2). These monitorizations are described as minimum in many practice guidelines, and sometimes monitors such as end-tidal carbon dioxide (ETCO2), body temperature, analgesia/nociception index (ANI) can be added to them.

The Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2).(1,2) When these parameters exceed physiological limits, patients require interventions consisting of various maneuvers or drug administration in order to maintain the normal functioning of the cardiorespiratory system. If we look at the scoring, a score of 8-10 is considered normal, a score of 5-7 indicates a situation that may require intervention, and a score of 1-4 indicates that the patient needs intervention.

The above-mentioned IPI is a relatively new tool, and there is limited data in the literature regarding its usability in patients undergoing interventional procedures under MAC.(3,4) In this study, we wanted to evaluate the safety of IPI in cases of pediatric endoscopy performed under sedation. Routine monitoring and drug applications for the procedure will be in accordance with the institutional protocols, and additional IPI monitoring will be performed. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • ASA 1-3 physical status
  • Elective upper or lower gastrointestinal tract endoscopy

排除标准

  • ASA physical status of 4 or more
  • Patients with any contraindication for off-site anesthesia

研究组 & 干预措施

Group P

Active Comparator

Patients sedated with propofol

干预措施: Integrated Pulmonary Index (IPI) monitoring (Device)

Group P

Active Comparator

Patients sedated with propofol

干预措施: propofol (Drug)

Group K

Active Comparator

Patients sedated with ketamine

干预措施: Integrated Pulmonary Index (IPI) monitoring (Device)

Group K

Active Comparator

Patients sedated with ketamine

干预措施: ketamine (Drug)

结局指标

主要结局

IPI-Ketamine

时间窗: Throughout the sedation procedure

Correlation of ketamine and IPI values

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruslan Abdullayev

Assist. Prof.

Marmara University

研究点 (1)

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