NCT05524220已完成不适用
Effect of Nasal Positive Airway Pressure Versus Standard Care on Oxygenation and Ventilation During Propofol-based Sedation for Colonoscopy in Patients With High Risk of Airway Obstruction: a Prospective Randomized Controlled Trial.
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2022年12月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Time Taken From Initiation of Induction to the First Airway Intervention
研究概览
简要总结
The purpose of this study is to to compare oxygenation and ventilation on spontaneously ventilating obese patients or those with diagnosed or undiagnosed Obstructive sleep apnea (OSA) undergoing day colonoscopy under Propofol based sedation, between the SuperNO2VA Et™ nasal positive airway pressure (PAP) device and routine care with face mask for oxygen (O2).
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 undergoing colonoscopy
- •American Society of Anesthesiology (ASA) Physical Status I-III
- •BMI ≥30 kg/m2 or suspected Obstructive Sleep Apnea
排除标准
- •Inpatient status
- •Active Congestive Heart Failure Exacerbation
- •Untreated ischemic heart disease
- •Acute exacerbation of respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma
- •Emergent procedures
- •Pregnancy
- •Previous enrollment in this study
- •Inability to provide informed consent
- •Additional medical testing planned for the same day
- •History of allergic reaction to Propofol
- •Tracheostomy
- •Supra-glottic or sub-glottic tumor
- •Gastrointestinal tract obstruction or delayed transit (including delayed gastric emptying, gastric bezoar, achalasia, toxic megacolon).
- •Prisoners
- •Unable to fit SuperNoVa
研究组 & 干预措施
Group A: Standard care with a facemask.
Active Comparator
干预措施: Standard care with a facemask. (Device)
Group B: SuperNO2VA™EtCO2
Experimental
干预措施: SuperNO2VA™EtCO2 (Nasal Oxygenating Ventilating Apparatus) (Device)
结局指标
主要结局
Time Taken From Initiation of Induction to the First Airway Intervention
时间窗: From Initiation of Induction to the First Airway Intervention (about 16 minutes)
次要结局
- Amount of Propofol Administered During Induction(Within 5 minutes of the start of anesthesia)
- Total Amount of Propofol Administered During the Procedure(during the procedure (about 45 minutes))
- Change in Alertness of Subject as Assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS)(prior to endoscopic intubation,during the procedure)
- Incidence of Procedural Interruptions as Assessed by the Number of Times the Endoscope is Removed From the Patient(From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes))
- Time Taken for Airway Maneuvers(From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes))
- Reason for Airway Maneuvers(From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes))
- Time Taken From Induction to Endoscopic Insertion(within 10 minutes of start of sedation)
- Number of Participants Who Received Airway Maneuvers(From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes))
- Duration of Procedural Interruptions as Assessed by the Length of Time the Endoscope is Removed From the Patient(From Initiation of Induction to removal of endoscope at the end of the procedure (about 45 minutes))
- Time Taken for the Entire Procedure(from start of procedure to end of procedure (about 45 minutes))
- Recovery Time as Assessed by the Time When Subject Was Ready for Discharge(at time of discharge( about one hour from end of procedure))
- Recovery Time as Assessed by the Actual Time When Subject Was Discharged(at time of discharge( about one and a half hour from end of procedure))
- Patient Satisfaction as Assessed by the Visual Analog Scale (VAS)(at time of discharge(about one hour from end of procedure))
- Number of Participants That Tolerated the SuperNO2VA™EtCO2(from start of procedure to end of procedure (about 45 minutes))
- Anesthesiologist Satisfaction Score as Assessed by the Visual Analog Scale (VAS)(end of procedure (about 45 minutes from start))
- Number of Participants That Had Incidences of Cardiac Complications(during the procedure (about 45 minutes))
研究者
Erikka L Washington
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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