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临床试验/NCT04520568
NCT04520568Unknown2 期

Preventing Deoxygenation With High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery: A Randomized Controlled Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
60
试验地点
1
主要终点
arterial partial pressures of oxygen

研究概览

简要总结

High-flow nasal cannula (HFNC) is a device that delivers10 to 70 L min-1 of heated, humidified 100% oxygen via nasal route. It provides positive airway pressure, decreases dyspnea, decreases the work of breathing, and improves comfort

详细描述

Beneficial effects of the HFNC system have been assessed based on 3 physiologic conditions: decreased dead space, a high concentration of inspiratory oxygen, and positive pressure in the oro-laryngeal cavity.Studies have shown that it improves oxygenation in various perioperative settings such as the apneic patients, patients with respiratory failure , and patients undergoing bronchoscopy

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
Single (Participant)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ASA physical status II and III,
  • •undergoing VATS

排除标准

  • •refusal of patients
  • •extrem of age

研究组 & 干预措施

HFNC group

Active Comparator

For HFNC group, F&P AIRVOTM 2 will be adjusted to give the patients the oxygen flow at 50L/min and the FiO2 at 1.0.Then after three minutes of preoxygenation, sedation will be conducted by giving 25 µg fentanyl and a bolus of 1 mg/kg propofol followed by continuous infusion of propofol using a target-controlled infusion system (TCI pump TE371; Terumo Corporation, TokyoJapan).

干预措施: High flow nasal cannula (Combination Product)

control group

Placebo Comparator

induction of general anaesthesia will be done using 2 mg/kg propofol and 1 µg/kg fentanyl. Double lumen tube will be facilitated by cisatracurium 0.2 mg/kg. Anaesthesia will be maintained with isoflurane 0.8 %-1% in 100% oxygen and maintenance dose of cisatracurium 0.02 mg/kg when needed. At the end of surgery, residual neuromuscular paralysis will be antagonized with neostigmine 0.05 mg/kg and atropine 0.01 mg/kg.

干预措施: CONTROL (Combination Product)

结局指标

主要结局

arterial partial pressures of oxygen

时间窗: two hours

an arterial blood sample will be taken after induction of anaesthesia then every 10 min till the end of the operation.

pH measurement

时间窗: two hours

an arterial blood sample will be taken after induction of anaesthesia then every 10 min till the end of the operation.

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

rehab zayed

Assisstant Professor of Anesthesia

Alexandria University

研究点 (1)

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