Comparison of Pre-warmed, Humidified High Flow Nasal Cannula (HFNC) Oxygen Therapy and Traditional Oxygen Therapy on Patient Comfort and Gas Exchange During Awake Craniotomy - A Single Centre, Prospective, Randomized, Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient comfort using VAS (1-10)
研究概览
简要总结
Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed oxygen/air mix flow through a face mask for a prolonged duration. This causes increased discomfort, inadequate breathing with the risk for hypoxia perioperatively. Humidified high flow nasal cannula (HFNC) oxygen therapy potentially improves patient comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the lung, compared to traditional oxygen administration using a face mask in patients undergoing awake brain surgery.
Results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of HFNC.
详细描述
Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed oxygen/air mix flow through a face mask for a prolonged duration. This causes increased discomfort, inadequate breathing with the risk for hypoxia perioperatively.
Hypothesis
Humidified high flow nasal cannula (HFNC) oxygen therapy improves patient comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the lung, compared to traditional oxygen administration using a face mask in patients undergoing awake brain surgery.
Methods: After obtaining ethics approval and written informed patient consent, 20 patients undergoing scheduled awake brain surgery will be randomized to either HFNC therapy or standard face mask. Evaluation of patient satisfaction, pain / dry upper airway along with drawing of arterial blood gases to measure oxygen/carbon dioxide content of the blood will be performed during and after the procedure. Lung ultrasound will be performed in the recovery room to determine the presence of atelectasis.
Expected results and Significance: We expect that HFNC improves patient comfort as well as breathing / arterial oxygen content in long-duration awake brain surgery. This could result in higher patient satisfaction, shorter times in PACU, a shorter requirement for oxygen therapy, decreased risk for hypoxia during surgery and better elimination of carbon dioxide - which could lead to better surgical conditions due to softer brain tissue and therefore shorter time for the surgical procedure. Potential positive results of this trial will be used to initiate a more extensive, multicenter trial to further characterize the potential impact of HFNC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients undergoing elective awake craniotomy
排除标准
- •pregnant females
- •Body Mass Index (BMI) > 40
- •elective postoperative mechanical ventilation/conversion to general anesthesia
- •denial of consent
- •obstructive sleep apnea requiring CPAP
- •severe COPD requiring home oxygen therapy
研究组 & 干预措施
HFNC
HFNC will be started at flow of 40 L/min and FiO2 of 40%.
干预措施: HFNC (Device)
Oxygen Mask
Standard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed.
干预措施: Oxygen Mask (Device)
结局指标
主要结局
Patient comfort using VAS (1-10)
时间窗: During surgical procedure, an average of 6 hours
Patient comfort during awake craniotomy
次要结局
- Gas exchange (blood gas analysis)(During surgical procedure (an average of 6 hours) and 15 minutes after PACU admission)
- Post-operative pulmonary atelectasis using Ultrasound evaluation(Up to 15 minutes before PACU discharge)
- Incidence of oxygen desaturation (number of events with SaO2 < 90%)(During surgical procedure, an average of 6 hours)