Respiratory and Hemodynamic Targets During General Anesthesia - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 485
- 试验地点
- 6
- 主要终点
- Feasibility: Proportion of eligible patients randomized
研究概览
简要总结
This trial is an investigator-initiated, multicenter, randomized, factorial, single-blind trial of multiple hemodynamic and respiratory targets during general anesthesia. These targets include blood pressure, positive end expiratory pressure, tidal volume, and fraction of inspired oxygen. Patients will be randomized to different targets using a factorial design, i.e., each patient is simultaneously randomized to four interventions. There will be five enrolling sites in the Central Denmark Region. 480 high-risk patients will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Age ≥ 18 years
- •American Society of Anesthesiologists (ASA) classification 3 to 5
- •Planned endotracheal intubation with positive pressure ventilation
- •Expected operating time ≥ 90 minutes
- •Certain types of surgery
排除标准
- •Inability to obtain consent (e.g., patient is unconscious, hyperacute surgery)
- •Known or suspected pregnancy
- •Out-patient/same-day surgery
- •Intubated prior to surgery
- •Clinical judgement by the anesthesiologist that any of the interventions could be potentially harmful to the patient
结局指标
主要结局
Feasibility: Proportion of eligible patients randomized
时间窗: Up to 90 days
Eligible patients will be defined as those meeting all inclusion criteria and none of the exclusion criteria 1 to 4.
Feasibility: Proportion of patient with adherence to the assigned interventions
时间窗: During surgery
Adherence will be defined as follows: The allocated positive end expiratory pressure (± 1 cm H2O), tidal volume (± 1 ml/kg), and FiO2 (± 5%) is used in a minimum of 90% of the randomized patients for the duration of the surgery. Vasopressors/inotropes are only initiated and continued if the blood pressure declines below the allocated target in at least 60% of the patients and at least 60% of time during general anesthesia, i.e., 60% of the registered blood pressures should be within +/- 10 mmHg of the target when vasopressor/inotropes are administered.
Feasibility: Proportion of patients with separation of mean arterial pressure
时间窗: During surgery
We aim to achieve at least 5 mmHg separation in mean/median mean arterial pressure for the three blood pressure groups targeting mean arterial pressure.
Feasibility: Proportion of patients lost to follow-up
时间窗: Up to 90 days
We aim to obtain data from more than 90% of patients still alive at 30- and 90-days follow-up.
次要结局
- Troponin-I(The day after the surgery)
- Proportion of patients with pulmonary post-operative complications (composite)(30 days)
- Proportion of patient with pneumonia(30 days)
- Proportion of patient with pulmonary embolism(30 days)
- Proportion of patient with acute kidney injury(30 days)
- Creatinine(The day after the surgery)
- Proportion of patient with major adverse cardiac events(30 days)
- Proportion of patients with myocardial injury after non-cardiac surgery(3 days)
- Alanine transaminase(The day after the surgery)
- Proportion of patients with emergence delirium(2 hours after the surgery)
- Opioid administered(24 hours)
- Proportion of patients with surgical site infections(30 days)
- Proportion of patients with who die(90 days)
- Health related quality of life(90 days)
- Proportion of patients with post-operative delirium(7 days)
- Post-operative pain(2 hours after the surgery)
- Quality of recovery(90 days)
- Proportion of patients with post-operative nausea and vomiting(2 hours after the surgery)
- Antiemetic treatment(24 hours)
- Length of hospital stay(Up to 90 days)
- Days alive and out of the hospital(Within 30 days)
- Proportion of patients with intraoperative complications(During surgery)
- Clavien-Dindo grading of complications(30 days)
- Proportion of patients with intensive care unit admission(30 days)
研究者
Lars Wiuff Andersen
Associate Professor
Aarhus University Hospital