High Flow Nasal Cannula in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography With Intravenous Sedation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Desaturation
研究概览
简要总结
The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Secondary outcomes include lowest average observed oxygen saturation (SpO2), snoring classification scores and satisfaction levels of both patients and gastroenterologists.
Participants will be randomized to 3 groups: G0 will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1 will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%.
详细描述
High flow nasal cannula provides adequate oxygenation in patients with compromised pulmonary function. Very few studies in the literature addressed its use with IV sedation in the OR. Successful application of High Flow nasal cannula in intravenous deep sedation cases in the OR will benefit in the reduction of airway manipulation and side effects from general anesthesia.
The aim of the current study is to compare the incidence of oxygen desaturation in patients receiving HFNC at different flow rates compared to conventional oxygen therapy via a simple cannula during ERCP. Secondary outcomes include lowest average observed oxygen saturation (SpO2), snoring classification scores and satisfaction levels of both patients and gastroenterologists.
A total of 60 patients undergoing ERCP will be equally randomized to 3 groups:
G0: will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1: will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%.
The three groups' intra-procedure and outcome parameters and variables will be compared. Statistical comparison will be made using the ANOVA, Student's t-test, and Chi-squared test. Level of statistical significance will be considered at p<0.05. ANOVA test will be performed to compare the different means between the four groups. Minimum and maximum 3 of 17 values will be recorded for each value in all 3 groups. A two sided P value of less than 0.05 will be considered statistically significant.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient able to give consent.
- •Patient undergoing deep sedation.
- •Patient undergoing ERCP procedure with no restrictions on the duration of the procedure.
- •Age > 18 years
- •Patients with BMI < 40 kg/m2
排除标准
- •Patient unable to give consent
- •Patient refusal to participate
- •Patients undergoing general anesthesia
- •age less than 18 years old
- •Patients with severe heart failure (EF<30%)
- •Morbidly obese Patients with BMI > 40 kg/m2
- •Patients with sleep apnea
- •Claustrophobia
- •Risk of aspiration due to severe reflux
- •Facial injury, facial malformation
- •Nasal defects/obstruction
- •ASA 4 patients
结局指标
主要结局
Desaturation
时间窗: During the surgery
Desaturation (SpO2≤95%) or a drop of more than 5% from baseline SpO2
次要结局
- Mean SpO2(During procedure)
- Lowest SpO2(During procedure)
- Snoring status(During procedure)
- Duration of the procedure(During procedure)
- Snoring snore(During procedure)
- Gastroenterologists' satisfaction(During procedure)
- Patients' satisfaction(During procedure)
研究者
Christian Rouphael
Instructor of Clinical Specialty
American University of Beirut Medical Center