High Flow Oxygen Therapy Versus Conventional Oxygen Therapy in Cardiac Surgery Patients-OPTICAR Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Successful weaning (i.e. absence of treatment failure) from Nasal Cannula High Flow Oxygenation post extubation from cardiac surgery within at least 48 hours
研究概览
简要总结
High flow oxygen therapy has been applied after extubation in cardiac surgery patients with uncertain efficacy. The current authors plan to conduct a prospective, randomized, controlled study of nasal high flow therapy (NHF) application with high (60L/min) or low flow (40L/min) oxygen mixture administration versus standard oxygen treatment (Venturi mask) after extubation of patients undergoing elective or non-elective cardiac surgery.
详细描述
Over the past decade, nasal high flow (NHF) has been introduced for oxygen therapy in adults. Its indications have been expanded, especially in cases of acute hypoxemic respiratory failure.
The device consists of an air/oxygen blender connected via an active heated humidifier to a nasal cannula, through a single limb, heated inspiratory circuit. It delivers a fraction of inspired oxygen (FiO2) from 21% to 100% with a flow rate up to 60 L/min. FiO2 adjustments are independent of the set flow rate so that the patient is given heated, humidified high-flow oxygen, with a flow that can be adjusted above the patient's maximum inspiratory flow rate, thereby increasing confidence about the actual FiO2 being delivered to the patient. These device characteristics make it more promising in comparison with conventional low- and high-flow oxygen devices (e.g., nasal cannula, non-rebreathing masks, Venturi masks), especially in patients with high inspiratory flow rates, such as patients with acute respiratory failure (ARF).
The benefits arising from application of oxygen with high flow rates via NHF are
- reduction in the entrainment of room air and thus ensuring higher and more stable FiO2 values,
- generation of positive airway pressures during expiration as a result of the expiratory resistance imposed to the patient's exhalation against the continuous high flow of incoming oxygen gas,
- improving mucociliary function and clearance of secretion by continuous heating and humidifying of the administered gas,
- reducing dead space ventilation and
- reducing work of breathing. All the aforementioned NHF mechanisms of actions exert various effects on the respiratory system, including improved gas exchange, lower respiratory rate and effort and improved lung mechanics which are correlated with more comfort and less subjective dyspnea.
Respiratory complications after cardiac surgery can affect morbidity and mortality, and increase the healthcare cost. Advanced age, duration of extracorporeal circulation, history of significant underlying cardiac or pulmonary disease and phrenic nerve injury are the main prognostic factors for post cardiac surgery respiratory complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Cardiac ICU adult patients
- •>18 years
- •After elective or urgent cardiac surgery
- •Successful Spontaneous Breathing Trial (SBT) with T-piece and FiO2=60%.
- •pO2/ FiO2 <200
- •Hemodynamically stable (160>SAP>90mmHg)
排除标准
- •Obstructive Sleep Apnea Syndrome supported by CPAP
- •COPD, officially diagnosed, respiratory failure with serum blood ph <7,
- •Patients with tracheostomy,
- •DNR status,
- •Glasgow Coma Scale score < 13,
- •Insufficient knowledge of Greek Language
- •Visual or hearing impairment.
结局指标
主要结局
Successful weaning (i.e. absence of treatment failure) from Nasal Cannula High Flow Oxygenation post extubation from cardiac surgery within at least 48 hours
时间窗: Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)
Successful weaning (i.e. absence of treatment failure as further described in methods) would be defined as = 0 when there would be avoided successfully any alternation with other mode of oxygen therapy, or re-intubation, or Non Invasive Ventilation. For all groups: Unsuccessful weaning (i.e. actual treatment failure as further described in methods) would be defined as =1 when there would not be avoided any alternation with other oxygen therapy, re-intubation, Non Invasive Ventilation
次要结局
- Successful maintenance of saturation O2 in Hemoglobulin within normal range with Venturi mask, FiO2: 60%, 15L/min(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Comfort and tolerance of treatment with Visual Analogue Scale with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Recording of pO2/FiO2 ratio with Venturi mask FiO2: 60%, 15L/min(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Comfort and tolerance of treatment with Visual Analogue Scale with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Successful maintenance of Respiration rate within normal range (12-20/min) on initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Successful maintenance of Respiration rate within normal range (12-20/min) with Venturi mask , FiO2: 60%, 15L/min(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Recording of pO2/FiO2 ratio with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Mobilization of accessory respiratory muscles with Venturi mask, FiO2: 60%, 15L/min To record any use of accessory respiratory muscles with Venturi mask , FiO2: 60%, 15L/min(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Comfort and tolerance of treatment with Visual Analogue Scale with Venturi mask , FiO2: 60%, 15L/min(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Successful maintenance of Respiration rate within normal range (12-20/min) on initial air flow of 40 L/min with Nasal Cannula High Flow Oxygenation(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Recording of pO2/FiO2 ratio with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation(Post extubation period up to 48 hours or ICU discharge)
- Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Mobilization of accessory respiratory muscles with initial air flow at 60 L/min with Nasal Cannula High Flow Oxygenation(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Mobilization of accessory respiratory muscles with initial air flow at 40 L/min with Nasal Cannula High Flow Oxygenation(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
研究者
Stavros Theologou
Principal Investigator
National and Kapodistrian University of Athens