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临床试验/NCT06231836
NCT06231836尚未招募不适用

High-flow Nasal Oxygenation Versus Standard Oxygenation for Gastrointestinal Endoscopy With Sedation in Obese Patients

Ain Shams University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月20日最近更新:
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:

  1. All patients will be subjected to full history taking and thorough physical examination.
  2. Age, sex and American Society Association (ASA) physical status were recorded.
  3. Preoperative investigations will be done to all patients including laboratory investigations.
  4. Oxygen saturation (SpO2) is recorded in ambient air
  5. preoperative monitoring including ECG, non-invasive blood pressure and SpO2 via pulse oximeter are displayed and recorded in each patient using standard anaesthesia monitors.
  6. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

RAMY AHMED

Assistant Professor of Anesthesia

Ain Shams University

研究点 (2)

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