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临床试验/NCT06947902
NCT06947902尚未招募不适用

Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures: a Randomized Study

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Number of participants that show an incidence of oxygen desaturation >5 %

研究概览

简要总结

The purpose of this study is to investigate which flow rate (higher versus lower) is most effective at increasing apneic time and preventing greater than 5% drop in desaturation, as well as assessing transcutaneous carbon dioxide (CO2) levels during airway procedures in children

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •undergoing laryngoscopy and bronchoscopy procedures at Children's Memorial Hermann Hospital (CMHH)
  • •weight greater than or equal to 5 kilograms and using flow rates between 5 to 45 liters per minute (BTPS)

排除标准

  • •Emergency type cases, tracheostomy patients, unrepaired cyanotic heart disease, nasal deformity/choanal atresia, or cautery/laser type procedures

研究组 & 干预措施

High flow

Experimental

干预措施: High flow (Device)

Low Flow

Experimental

干预措施: Low Flow (Device)

结局指标

主要结局

Number of participants that show an incidence of oxygen desaturation >5 %

时间窗: from start of procedure to end of procedure (about 1 hour)

次要结局

  • Apnea time measured in seconds or minutes(from start of procedure to end of procedure (about 1 hour))
  • Number of Participants With Surgical Interruptions Due to Desaturation(from start of procedure to end of procedure (about 1 hour))
  • Oxygen nadir level(from start of procedure to end of procedure (about 1 hour))
  • Transcutaneous CO2 measurements throughout procedure(from start of procedure to end of procedure (about 1 hour))
  • Adverse events related to device itself (nasal pain, skin irritation)(from baseline to end of study (1 month after baseline))

研究者

发起方
The University of Texas Health Science Center, Houston
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhen Huang

Associate Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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