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临床试验/NCT06054022
NCT06054022已完成不适用

Comparing Intraoperative High Flow Nasal Cannula Therapy and Convetional Oxygen Therapy in Preventing Perioperative Hypoxaemia In Elderly Patients Undergoing Orthopaedic Surgery: A Randomized Controlled Study

Universiti Kebangsaan Malaysia Medical Centre2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年7月7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
50
试验地点
2
主要终点
Incident of intraoperative desaturation

研究概览

简要总结

To study the effect of high flow nasal cannula in comparisons with nasoprong used intraoperatively in patients oxygenation status

详细描述

To observe the effect of high flow nasal cannula used intraoperatively compared to normal oxygen therapy (nasoprong) at a same fraction of inspired oxygen (FiO2) in elderly patients who are going for orthopaedic surgeries under central neuraxial block.

oxygenation will be access with intermittent blood gas. atelectasis will be access via chest x-ray , compared to a baseline chest x-ray, validated by a blinded radiologist

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

there will be no masking except for the radiologist who compares the postoperative chest x-ray with the baseline

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) I, II or III patients.
  • Patients age 60 years and above
  • Patients scheduled for total knee replacement therapy and hip surgeries under central neuraxial block under the elective and emergency list.

排除标准

  • Patients with pre-operative spO2<94%
  • Patients delirious or demented / unable to give consent.
  • Patients with pre-existing pneumonia (defined as the initiation of antibiotics for suspected infection with one or more of the following: new or changed sputum; new or changed lung opacities; fever; white blood cell count >12 × 109 litre-1 )15

结局指标

主要结局

Incident of intraoperative desaturation

时间窗: From induction time until end of surgery

desaturation is taken as any spO2 \<94%

Patient comfort on high flow nasal cannula

时间窗: At end of surgery till discharge to ward (recovery area)

Patient rate comfort level using Visual Numerical Scale. The scale of 1 to 5 with 1 being extreme discomfort, 3 neutral and 5 extreme comfort

Atelactasis

时间窗: From end of operation until 24 hours post surgery

Incident of postoperative atelectasis by compraring the preoperative and postoperative chest x ray by a radiologist

次要结局

  • Length of hospital stay(Time of hospital admission to time of discharge up to 30 days which ever come first)

研究者

发起方
Universiti Kebangsaan Malaysia Medical Centre
申办方类型
Other
责任方
Sponsor

研究点 (2)

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