NCT04596735已完成不适用
A Prospective Evaluation of Extubation Criteria in Patients Greater Than 59 Years of Age Following Anesthesia and Non-cardiac Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Extubation Success or Extubation requiring Intervention
研究概览
简要总结
Prospectively evaluate the predictive value of individual pre-specified clinical extubation criteria for extubation success
详细描述
Perform a prospective observational study to evaluate routine criteria commonly used to extubate elderly patients in the operating room after non-cardiac and non-thoracic surgery to ultimately reduce the incidence of near-term reintubation and by extension other respiratory complications
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 60 years of age
- •Patients undergoing general endotracheal anesthesia for surgery or invasive diagnostic procedures that are anticipated to be extubated immediately following the procedure
排除标准
- •Age<60 years of age
- •Patients with a tracheostomy in - situ (pre-existing or placed as part of the index procedure)
- •Patients undergoing cardiac surgical procedures
- •Patients undergoing general endotracheal anesthesia who are not anticipated to be extubated immediately following the surgical procedure
- •Patients with delayed extubations in the post anesthesia care unit or intensive care unit)
- •Patients undergoing TIVA (Total Intravenous Anaesthesia)
- •Patient with an initial room air SpO2<93%
- •Patients with VADS (ventricular assist device) undergoing non-cardiac surgery
- •Thoracic surgical procedures
- •Patients on home oxygen
- •Patients getting general anesthesia with supraglottic airway
结局指标
主要结局
Extubation Success or Extubation requiring Intervention
时间窗: Day 1
Quality of extubation will be assessed using a standard rubric for all extubation.
Presence or Absence of specific extubation criteria.
时间窗: Day 1
Assess the presence of specific extubation criteria met during extubation from the following list: Following Commands, Tidal volume\>4 cc/kg, Conjugate gaze, End-tidal CO2 (ETCO2) \<55 mmHg, ET agent concentration \< (Des 1%, Iso \<=0.2%, Sevo \<0.3%, oxygen saturation (SpO2) \> 94%,Qualitative or quantitative Tetralogy of Fallot (TOF), Purposeful Movement, 5 second head lift, Spontaneous Respiratory Rate \>=8 bpm at extubation, eye opening
次要结局
- Anesthesia Time during procedure(during procedure)
- Number of Participants with Preoperative Exposures (ASA) American Society of Anesthesiologists Emergency Status(Preoperative)
- Number of Participants with Preoperative Exposures (COPD) Chronic obstructive pulmonary disease(Preoperative)
- Number of Participants with Preoperative Exposures (Dementia)(Preoperative)
- Number of Participants with Preoperative Exposures (obstructive sleep apnea by history or STOP BANG) (snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference and gender)(Preoperative)
- Number of Participants with Preoperative Exposures (Sleep Disordered breathing by history or STOP BANG) (snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference and gender)(Preoperative)
- Number of Participants with Preoperative Exposures (Neuro-degenerative disorders)(Preoperative)
- Number of Participants with Preoperative Exposures (Heart failure)(Preoperative)
- Number of Participants with Preoperative Exposures (Opioid naïve)(Preoperative)
- Number of Participants with Preoperative Exposures (Diabetes)(Preoperative)
- Number of Participants with Preoperative Exposures (ESRD) End-Stage Renal Disease(Preoperative)
- Number of Participants with Preoperative Exposures (CVA) cerebrovascular accident - medical term for a stroke(Preoperative)
- Number of Participants with Preoperative Exposures (Chronic Restrictive Lung disease)(Preoperative)
- Number of Participants with Preoperative Exposures (Current Smoker)(Preoperative)
- Number of Participants with Preoperative Exposures (Inhalational agent used for maintenance)(Preoperative)
- Number of Participants with Preoperative Exposures (Use of (NMB) Neuromuscular Blocker(during procedure)
- Number of Participants with Preoperative Exposures (Use of Midazolam)(during procedure)
- Number of Participants with Preoperative Exposures (Use of opioid agonist during preoperative or intraoperative phase)(during procedure)
- Number of Participants with Preoperative Exposures (Use of blood or other blood products such as platelets, FFP(Fresh frozen plasma), or Cryo)(during procedure)
- Number of Participants with Preoperative Exposures (Regional Anesthesia other than local infiltration)(during procedure)
- Number of Participants with Preoperative Exposures (Type of inhalational agent used for maintenance)(during procedure)
- Number of Participants with Preoperative Exposures (Use of train of 4 monitoring)(during procedure)
- Number of Participants with Preoperative Exposures (Use of Sugammadex for reversal)(during procedure)
- Number of Participants with Preoperative Exposures (Use of Neostigmine for reversal)(during procedure)
- Number of Participants with Preoperative Exposures (Difficult Airway)(during procedure)
- Number of Participants with Preoperative Exposures (Intracranial Procedure)(during procedure)
- Number of Participants with Preoperative Exposures (positive end-expiratory pressure (PEEP)(during procedure)
- Number of Participants with Preoperative Exposures (Surgical Procedure)(during procedure)
- Number of Participants with Preoperative Exposures (Open Abdominal)(during procedure)
- Number of Participants with Preoperative Exposures (Laparoscopic or Robotic Procedure)(during procedure)
- IV fluid volume(during procedure)
- volume of blood products(during procedure)
- types of blood products(during procedure)
- Number of Participants with Preoperative Exposures (use of colloid)(during procedure)
- volume of colloid(during procedure)
研究者
研究点 (1)
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