Comparison of Oxygenation and Ventilation With a Novel Nasal Mask Versus Standard of Care During Colonoscopy: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Time to First Intervention
研究概览
简要总结
Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy.
The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.
详细描述
Colonoscopy has become an essential part of the patient management, especially in the field of colorectal cancer prevention. About 15 million colonoscopies were done in the United States in 2012. Data from United States and European countries suggest that the majority of investigations are performed with the aid of sedation. Since sedation can cause significant respiratory depression, resulting in hypoxia, especially in obese and elder populations who are more likely to undergo colonoscopy, usually oxygen is provided to patients via a nasal cannula to minimize the risk of hypoxia.
Nasal continuous positive airway pressure (nCPAP) has been shown to effectively relieve upper airway obstruction in patients with OSA as it creates a pneumatic stent in the hypopharynx that reduces obstruction and allows for continuous oxygenation. Nasal ventilation was also proven to be more effective than combined oral-nasal ventilation during induction of general anesthesia in adult subjects. However, it is not clear if nasal mask can be used safely for oxygenation and ventilation in patients undergoing colonoscopy.
The SuperNO2VA™ device is a new commercially available nasal mask that provides both nasal CPAP and nasal mask ventilation. The objective of this study is to compare the efficacy of oxygenation and ventilation during colonoscopy using the novel nasal mask, SuperNO2VA™, and standard care with nasal cannula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients 18 years or older
- •BMI of 30-50
- •ASA 1-3 Scheduled for colonoscopy with sedation
排除标准
- •Untreated ischemic heart disease
- •Acute and chronic respiratory disorders, including COPD and asthma
- •Emergent procedures
- •Planned use of an invasive airway (ie: supra-glottic device, LMA, etc)
- •Pregnant women
- •Nasal or oral disease resulting in difficulty of either nasal breathing or mouth breathing
- •Patient refusal
研究组 & 干预措施
Oxygen via nasal cannula (Standard of Care)
The anesthesia provider will supply oxygen via nasal cannula at oxygen flow rates as per standard of care routine at Vanderbilt University Medical Center.
干预措施: Oxygen via nasal cannula (Device)
Oxygen via SuperNO2VA nasal mask
The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
干预措施: Oxygen via SuperNO2VA nasal mask (Device)
结局指标
主要结局
Time to First Intervention
时间窗: Usually 5 minutes
The time period between the beginning of standard of care propofol bolus and/or start of propofol infusion to time of initiation of the first intervention for airway management.
次要结局
- Duration of Intervention(Duration of colonoscopy procedure (usually 30 minutes))
- Oxygen Saturation Reading- Median(Duration of colonoscopy procedure (usually 30 minutes))
- Respiratory Rate (RR)(Duration of colonoscopy procedure (usually 30 minutes))
- Number of Participants With Oxygen Saturation- Reading Below 90%(Duration of colonoscopy procedure (usually 30 minutes))
- Oxygen Saturation- Lowest Reading(Duration of colonoscopy procedure (usually 30 minutes))
- Number of Subjects Receiving Interventions for Airway Management(Duration of colonoscopy procedure (usually 30 minutes))
- Tidal Volume (VT)(Duration of colonoscopy procedure (usually 30 minutes))
- Minute Ventilation (MV)(Duration of colonoscopy procedure (usually 30 minutes))
研究者
Koffi Michael Kla
Associate Professor
Vanderbilt University Medical Center