Study of Asymmetrical High Flow Nasal Cannula Oxygenation (HFNCO) vs Standard HFNCO on Cardiac Surgical Patients Postoperatively
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Successful weaning (i.e. absence of treatment failure) from Asymmetrical 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 a well-known successful efficacy. The current authors plan to conduct a prospective, randomized, controlled study of the Asymmetrical device Nasal Cannula High Flow Oxygenation (HFNCO) application on high flow (60L/min) with 60% fiO2 administration versus Conventional device Nasal Cannula High Flow Oxygenation (HFNCO) application on high flow (60L/min) with 60% fiO2 administration and versus Conventional oxygen treatment (Venturi mask) after extubation of patients undergoing elective or non-elective cardiac surgery.
详细描述
Over the last decade, High Flow Nasal Cannula Oxygenation,(HFNCO) has proven successfully its capability in the management of hypoxemic respiratory failure patients post cardiac surgery. Efficient oxygenation has been recorded in meta-analyses on study population research with BMI > 30 . Moreover, in a recent meta-analysis, it has been documented that the use of HFNCO required less need for upgrade of respiratory support . Similar findings were documented in a study of two different variations of HFNCO treatment as compared with Conventional oxygen therapy (Venturi mask) .
A modified version (Asymmetrical) of HFNCO came on the surface recently whereas the (L) nasal prong has a larger diameter compared with the (R) prong of the nasal cannula.
Research results on hypoxemic patients and laboratory models also revealed interesting measurements on specific respiratory parameters such as minute volume ventilation, respiratory rate, and work of breathing as compared with conventional HFNCO. In addition, there were documented higher resistance flow rates which achieved higher PEEP rates in favor of lung alveoli.
On the other hand, there exists documentation with positive aspects that support the use of a non-rebreathing mask / Venturi mask or surgical mask fixed on top of nasal prongs of HFNCO to augment the fiO2 which finally ends up on the patient.
Aim of the study. The primary goal of the study is the efficacy of the Asymmetrical HFNCO on cardiac surgical patients post-extubation as compared with Conventional HFNCO The secondary goal of the study is the comparison of initial Asymmetrical HFNCO parameters versus a) the avoidance of upgrading Asymmetrical HFNCO supported by a non-rebreathing mask fixed on top of that, versus b) the avoidance of upgrading Asymmetrical HFNCO to Non-Invasive Ventilation (NIV).
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 <150
- •Hemodynamically stable (160>SAP>90mmHg)
排除标准
- •Obstructive Sleep Apnea Syndrome supported by CPAP mask on ventilator
- •COPD, officially diagnosed, respiratory failure - on exacerbation with serum blood pH <7,
- •Patients with tracheostomy,
- •DNR status,
- •Glasgow Coma Scale score < 13,
- •Insufficient knowledge of the Greek Language
- •Visual or hearing impairment.
研究组 & 干预措施
Study Group 1, Asymmetrical HFNCO
The intervention involves implementing the Asymmetrical High Flow Oxygenation Nasal Cannula as an oxygen treatment at Study Group 1. In contrast, oxygen supply was provided via conventional High Flow Nasal Cannula as a standard oxygen patients' treatment
The first Study Group will include patients on Asymmetrical High Flow Nasal Cannula Oxygenation with initial settings of FiO2=60% and gas flow=60L/min.
干预措施: Asymmetrical High Flow Nasal Cannula Oxygenation (Device)
Study Group 2, Conventional HFNCO
The intervention involves implementing High Flow Nasal Cannula Oxygenation as an oxygen treatment in Study Group 2.
The second Study Group will include patients on Conventional High Flow Nasal Cannula Oxygenation with initial settings of FiO2=60% and gas flow=60L/min.
干预措施: Conventional High Flow Nasal Cannula Oxygenation (Device)
Control Group
No Intervention: Control group In the third group (control group) all patients will receive oxygen treatment according to the standard practice of our cardiac ICU department, i.e., Venturi mask with FiO2=60% and flow of 12L/min.
In this group, all patients will receive the usual standard of care, with no other interventions included
结局指标
主要结局
Successful weaning (i.e. absence of treatment failure) from Asymmetrical 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 Conventional Nasal Cannula High Flow Oxygenation, Non Invasive Ventilation, or re-intubation 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 Conventional Nasal Cannula High Flow Oxygenation, Non Invasive Ventilation or re-intubation.
次要结局
- Successful maintenance of Respiration rate within the normal range (12-20/min) on initial airflow at 60 L/min, 60% fiO2 on Asymmetrical Nasal Cannula High Flow Oxygenation(Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)])
- Successful maintenance of Respiration rate within normal range (12-20/min) with Venturi mask , FiO2: 60%, 15L/min(Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)])
- Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial airflow at 60 L/min & 60% fiO2 on Conventional Nasal Cannula High Flow Oxygenation(Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)])
- Successful maintenance of saturation O2 in Hemoglobulin within normal range with Venturi mask, 60% fiO2, 12l/min(Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)])
- Mobilization of accessory respiratory muscles with initial airflow at 60 L/min & 60% fiO2 on Conventional 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 the normal range (12-20/min) on the initial airflow of 60 L/min, 60% fiO2 with Conventional Nasal Cannula High-Flow Oxygenation(Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)])
- Recording of pO2/FiO2 ratio with initial airflow at 60 L/min & 60% fiO2 with Conventional Nasal Cannula High Flow Oxygenation(Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)])
- Successful maintenance of saturation O2 in Hemoglobulin within normal range with initial airflow at 60 L/min & 60% fiO2 on Asymmetrical Nasal Cannula High Flow Oxygenation(Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)])
- Mobilization of accessory respiratory muscles with Venturi mask, 60% fiO2, 12l/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 60 L/min & 60% fiO2 with Asymmetrical Nasal Cannula High Flow Oxygenation(Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)])
- Recording of pO2/FiO2 ratio with Venturi mask, 60% fiO2, 12l/min(Up to at least 48 hours post extubation or until ICU discharge (predicted cardiothoracic ICU stay could occasionally extend up to 7 days)])
- Mobilization of accessory respiratory muscles with initial airflow at 60 L/min & 60% fiO2 on Asymmetrical Nasal Cannula High Flow Oxygenation(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 on Asymmetrical Nasal Cannula High Flow Oxygenation with initial airflow at 60 L/min & 60% fiO2(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Percentage of participants presenting unsuccessful (failed) implementation of Asymmetrical Nasal Cannula High Flow Oxygenation treatment(Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge])
- Number of participants with re-intubation in the ICU(Post cardiothorasic ICU admission period up to 3 months or until actual Hospital discharge)
- Comfort and tolerance of treatment with Visual Analogue Scale on Conventional Nasal Cannula High Flow Oxygenation with initial airflow at 60 L/min & 60% fiO2(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, 60% fiO2, 12l/min(Post extubation period up to 48 hours or ICU discharge (if cardiothoracic ICU stay was <48 hours))
- Length of Stay in the Hospital(Post cardiothorasic ICU admission period up to actual hospital discharge)
- Number of participants with death in the cardiothoracic ICU post extubation(Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge])
- Number of participants with any Adverse Events in the Hospital (respiratory-chest infection, pneumothorax, delirium, grand mal, acute renal failure, major bleeding - tamponade, cardiac arrest )(Post cardiothorasic ICU admission period up to 3 months or until actual Hospital discharge)
- Percentage of participants presenting unsuccessful (failed) implementation of Venturi mask oxygen therapy(Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge])
- Length of Stay in the ICU(Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge])
- Number of participants with Atrial Fibrillation in the ICU post extubation(Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge])
- Number of participants with any Adverse Events in the ICU (respiratory-chest infection, pneumothorax, delirium, grand mal, acute renal failure, major bleeding - tamponade )(Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge])
- Percentage of participants presenting unsuccessful (failed) implementation of Conventional Nasal Cannula High Flow Oxygenation treatment(Post cardiothoracic ICU admission period up to 48 hours or untiI actual cardiothoracic ICU discharge])
研究者
Stavros Theologou
Principal Investigator, Stavros Theologou, RN, Deputy Nurse in Charge - Cardiac Surgery ICU, MSc, MHM, PhD
National and Kapodistrian University of Athens