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临床试验/CTRI/2024/05/067510
CTRI/2024/05/067510尚未招募不适用

Comparison of apnoeic oxygenation efficiency using high flow nasal cannula at two different flow rates in patients posted for surgery under general anaesthesia

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
56
试验地点
1
主要终点
PaO2 in both the groups.

研究概览

简要总结

This study is a prospective, randomized, comparative, single centre study comparing the efficiency of apnoeic oxygenation using high flow nasal cannula at 40 L/min and 60L/min in adult patients posted for surgery under general anaesthesia. A total of 56 patients will be recruited with 28 patients in each group. We hypothesized that HFNC flow of 40 L/min during apnoea period should provide similar oxygenation as that obtained by HFNC flow of 60 L/min. In both groups, pre-oxygenation will be done using high flow nasal cannula at 40 L/min for 3 minutes. After induction, the flow rate will be kept at 40 L/min in group F and increased to 60 L/min in group S for 3 minutes after which a definitive airway will be secured. The primary outcome will be partial pressure of arterial oxygen (PaO2) at the end of 3 minutes of apnoeic oxygenation in both groups. The secondary outcomes will be mean difference in PaO2 and PaCO2 levels in both groups (baseline, after 3 minutes of pre-oxygenation, after 3 minutes of apnoeic oxygenation, End-tidal oxygen (FETO2) and End-tidal carbon dioxide (ETCO2) after securing a definitive airway and after 3 minutes, percentage of population with hypoxemia (SpO2 < 92%), patient comfort during pre-oxygenation immediately before induction on a 5 point Likert scale.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I and II.

排除标准

  • Any known contraindication to HFNC: bleeding in nose or oropharynx, pre-existing nasal obstruction, greater than 50 percent of nares occluded by nasal prongs.
  • Patients on oxygen therapy.
  • Any underlying chronic or restrictive lung disease (kyphoscoliosis, burn contractures).
  • Previous lung surgery.
  • BMI greater than 35 kg per meter square.
  • Planned for awake intubation or a difficult airway.
  • Any contra-indication to continuous positive airway pressure (CPAP) treatment.
  • Pregnant patients, autonomic neuropathy, history of gastro-esophageal reflux disease(GERD).

结局指标

主要结局

PaO2 in both the groups.

时间窗: At the end of 3 minutes of apnoeic oxygenation

次要结局

  • Mean difference in PaO2 and PaCO2 levels in both groups (baseline, after 3 minutes of pre-oxygenation, after 3 minutes of apnoeic oxygenation) .(End tidal oxygen (FETO2) and End tidal carbon dioxide (ETCO2) after securing a definitive airway and after 3 minutes.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nitya Nyalakonda

Maulana Azad Medical College

研究点 (1)

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