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临床试验/CTRI/2020/03/023855
CTRI/2020/03/023855尚未招募不适用

Comparison of oxygen delivery methods for patient undergoing monitored anesthesia care in endoscopic procedures.

Pramukhswami medical college1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年10月3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
66
试验地点
1
主要终点
Hypoxia

研究概览

简要总结

Patient will undergo pre-anesthesia workup ,written and informed consent will be taken. All patient will be kept nil by mouth 8 hrs for solid 2 hrs for clear liquid, patient with concurrent illness take medication.Preprocedural preaparation by lidocaine oral topical solution, topical pharyngeal spray with 10% lidocaine spray for upper endoscopy. Patient randomly allocated into two group using winpipe software a) nasal prongs b) t piece via nasopharyngeal airway with FiO2 between 40-60%. Patients vitals(Spo2, heart rate,respiratory rate,blood pressure) are monitored on table, every 5 mins till the end of procedure. Adverse events and correction done such as hypoxia- head tilt, chin lift,securing airway by nasopharyngeal airway, increase flow of O2 or intermittent O2 flush, bag and mask ventilation, bradycardia- fluid and vasopressor, body movement - additional dose of anesthetic drug, bleeding from nose - local pressure application, Aspiration- oral nasal suctioning interruption of procedure and securing definite airway , Ramsay sedation score will be maintained >4 during endoscopy. We focus on comparing two different methods of oxygen delivery in flexible endoscopic procedure and thereby finding out the best method of oxygen delivery for safe and efficient monitored anesthesia care for patients undergoing flexible endoscopic procedure.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •All patients ASA I,II,III, IV undergoing flexible endoscopy under monitored anesthesia care.

排除标准

  • •Patient requiring endotracheal intubation 2) Patient who have endotracheal tube insitu 3) Inadequate NBM 4) Tracheostomised patient 5) Allergy to topical anesthetics 6) Nasal deformities(deformation of nasal septum, visible distorsion or deviation from midline of nasal septum) 7) Patient on anticoagulants and with deranged coagulation profile 8)Lack of informed consent.

结局指标

主要结局

Hypoxia

时间窗: SPO2 less than 90 percentage for at least 15 secconds

次要结局

  • 1) Vitals and sedation level(2) Adverse events)

研究者

申办方类型
Private medical college

研究点 (1)

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