Efficacy and Safety of Using Noninvasive Ventilation Associated With Recruitment Maneuver in the Postoperative Period of Coronary Artery Bypass Grafting: a Controlled Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Oxygenation improvement
研究概览
简要总结
Cardiac surgery can evolve with complications in the postoperative period, atelectasis and hypoxemia are the major pulmonary dysfunctions. They can lead to a prolonged length of stay in the hospital, increasing morbidity and mortality. In order to prevent or reduce such complications noninvasive ventilation (NIV) has been used in the postoperative period in a prophylactic and therapeutic way. The use of positive end-expiratory pressure (PEEP) is widely practice in intensive care unit (ICU), being used in patients under mechanical ventilation, NIV and exercises with intermittent positive pressure. The recruitment maneuver (RM) consists of sustained increase of pressure in the airway using PEEP in individuals with hypoxemia, in order to minimize the deleterious effects from alveolar collapse, providing a more homogeneous ventilation of the pulmonary parenchyma increasing the pulmonary area available for gas exchange and, consequently, arterial oxygenation. In recent years the increase in the application of PEEP in cardiac patients under has shown great benefits and the use of NIV to improve oxygenation by the reversal of atelectasis is already used and recommended in hospital routine. Despite NIV being used in great proportion, the relevant literature is poor in showing studies with NIV associated with RM in postoperative period of cardiac surgery. Therefore, the aims of this study are to evaluate if the use of NIV associated with RM improves oxygenation and if it can be safely applied in coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB) postoperative patients.
详细描述
This work was a controlled and randomized clinical trial, where patients were analyzed in postoperative period of CABG with CPB. The protocol study was approved by Ethics Committee of the Faculty of Medicine, University os São Paulo and the Ethics Committee of the Hospital do Coração. Written informed consent was obtained from the patients or their surrogates at the thime of their enrollment.
Patients, doctors and nursing team were blinded to which group the patient was allocated, only the physiotherapy team, responsible for applying NIV therapy in the study, was aware of group allocation after randomization.
All the patients were ventilated in Servo I (MAQUET Critical Care AB™, Sweden) and used the FitLife total face mask (Philips Respironics™, USA).
Randomization was performed using a computer-based software. Patients eligible to the study were randomly assigned to the Control Group (CG) or Recruitment Group (RG).
CG used NIV for 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, fractional inspired oxygen (FiO2) for a peripheral oxygen saturation (SpO2) ≥ 95%. RG used NIV with RM with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each level, then being maintained in NIV for 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, FiO2 for a SpO2 ≥ 95%.
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
- 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
- •Patients aged 18 years or over;
- •Hypoxemia defined by ratio PaO2/FiO2 < 300 in extubation;
- •Glasgow Coma Scale > 11 after extubation;
- •Chest radiograph with radiological atelectasis score ≥ 2 The radiological score of atelectasis: 0, without atelectasis; 1, line of atelectasis or discrete infiltration; 2, partial atelectasis; 3, lobar atelectasis and 4, bilateral lobar atelectasis.
排除标准
- •Use of vasoconstrictor drugs in increasing doses throughout the last two hours (norepinephrine increasing ≥ 0.5 mcg / kg / min, or increase of dopamine ≥ 5mcg/kg/min) or arterial pressure <65 mmHg;
- •Presence of a tracheostomy;
- •Global initiative for Obstructive Lung Disease (GOLD) classification > 2 and pulmonary fibrosis;
- •Contraindication to use of NIV;
- •Refuse of RM by the surgeon / doctor in charge.
研究组 & 干预措施
recruitment group (RG)
After extubation the patient who was randomized to the Recruitment Group (RG) used noninvasive ventilation (NIV) associated with recruitment maneuver with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each, then being maintained in NIV until 30 minutes with pressure support for a tidal volume of 6 mL/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen (FiO2) for a peripheral oxygen saturation (SpO2) ≥ 95%.
干预措施: recruitment group (RG) (Other)
control group (CG)
After extubation the patient who was randomized to the Control Group (CG) used noninvasive ventilation (NIV) for 30 minutes with pressure support for a tidal volume of 6 ml/Kg, PEEP 8 cm H2O, FiO2 for a SpO2 ≥ 95%.
干预措施: control group (CG) (Other)
结局指标
主要结局
Oxygenation improvement
时间窗: from date of extubation until the date of ICU discharge, approximately one month
Arterial blood gas sample was collected in pressure support ventilation on the day of extubation and on the following days, it was collected after 2 minutes in room air, daily until ICU discharge. Oxygenation improvement was the difference between partial oxygen pressure at the day of ICU discharge and the day of extubation.
次要结局
- Extubation failure rate(from date of extubation until the date of ICU discharge, approximately one month)
- Atelectasis score improvement(from date of extubation until the date of ICU discharge, approximately one month)
- ICU lenght of stay(from date of ICU admission until the date of ICU discharge, approximately one month)
- Mortality intrahospital(from date of hospital admission until the date of hospital discharge, approximately one month)
- Barotrauma(from date of extubation until the date of ICU discharge, approximately one month)
- Arrhythmia(from date of extubation until the date of ICU discharge, approximately one month)
- Hemodynamic instability(from date of extubation until the date of ICU discharge, approximately one month)
研究者
Mieko Cláudia Miura
Post graduating, Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of São Paulo
University of Sao Paulo