NCT06231836尚未招募不适用
High-flow Nasal Oxygenation Versus Standard Oxygenation for Gastrointestinal Endoscopy With Sedation in Obese Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- occurence of hypoxia
研究概览
简要总结
Hypoxaemia is a major complication during gastrointestinal endoscopy (GIE) procedures (upper/lower) when performed under deep sedation in the procedure room especially with a body mass index above 30 kg/m².
The objective of the present work is to compare the use of High-flow nasal oxygenation (HFNO) with Standard oxygen therapy (SOT) in obese patient undergoing GIE.
详细描述
• Pre-operative settings:
- All patients will be subjected to full history taking and thorough physical examination.
- Age, sex and American Society Association (ASA) physical status were recorded.
- Preoperative investigations will be done to all patients including laboratory investigations.
- Oxygen saturation (SpO2) is recorded in ambient air
- preoperative monitoring including ECG, non-invasive blood pressure and SpO2 via pulse oximeter are displayed and recorded in each patient using standard anaesthesia monitors.
- Arterial Blood Gase(ABG) are sampled on room air .
Intraoperative settings:
- According to ASA standard monitoring criteria (pulse oximeter, non-invasive blood pressure cuff and electrocardiogram) will be attached to all patients.
- All patients will be monitored for peripheral oxygen saturation, blood pressure, Electrocardiogram through the whole operation.
- Intravenous access will be applied under aseptic condition, SpO2 is recorded in ambient air.
- Preoxygenation with the oxygen device (face mask 10L/min) for 3 min before starting the induction.
- The induction is done by An initial bolus of propofol (0.5-1 mg/kg) is administered intravenously, followed by a repeated bolus (10-20 mg) according to the patient's condition, or a continuous propofol infusion (2-6 mg/kg/h, with an additional bolus administered as needed) The infusion rate is chosen according to the desired sedation depth and the patient risk profile .
- In group A(intervention group) : preoxygenation for 3 min ,then start induction .Once the eyelash reflex has disappeared O2 is administered by HFNO with flow 70L/min and the FiO2 is set at 40%,The decision to set the FiO2 at 40% was made to obtain a similar FiO2 in both groups and to reduce the risk of hyperoxia and hypercapnia.
- In group B(control group):preoxygenation for 3 min, after induction ,once the eyelash reflex has disappeared, O2 is administered by nasal cannula at 6L/min.
- The investigator- chose to set a similar initial FiO2 in both groups during preoxygenation and procedure not to disadvantage the SOT group, as similar FiO2 will allow to determine if the HFNO- induced Positive End Expiratory Pressure PEEP and dead space washout effects could be beneficial.
- During the procedure, in both groups, if deemed necessary, the investigator can raise the FiO2 or the gas flow in case of desaturation or for any reason.
- In case of major intolerance, HFNO or SOT can be stopped and replaced by any other oxygen therapy technique.
- Tracheal intubation is allowed if necessary. In every case, investigators have to record all events in the case report form.
Post-operative settings:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, 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
- 否
入选标准
- •Obese patient with body mass index (BMI) >30
- •Patients scheduled for GIE (upper and/or lower endoscopy), for which sedation with maintenance of spontaneous breathing is planned.
- •Patients older than 18 years old.
排除标准
- •Gastrointestinal endoscopy (GIE) performed in emergency.
- •Necessity to intubate the patient for the procedure.
- •Patient under oxygen therapy at home.
- •Tracheostomised patient.
- •Pregnancy.
- •Patient not affiliated or excluded from social protection
结局指标
主要结局
occurence of hypoxia
时间窗: during the procedure
SpO2 \<90%
次要结局
- number of participants needed to use mask ventilation or to perform any airway intervention(during the procedure)
- occurence of hypercapnia (end tidal carbon dioxide >40 millimeter mercury)(during the procedure)
- occurence of hypoxia(from recovery room admission till discharge up to one hour)
- The rate of modifications of oxygen flow in both groups and of the FiO2 in the HFNO group.(during the procedure)
- number of participants needed non- invasive ventilation, laryngeal mask airway or for intubation(during the procedure)
- number of participants needed to stop the procedure(during the procedure)
研究者
RAMY AHMED
Assistant Professor of Anesthesia
Ain Shams University
研究点 (2)
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