Effect of Boussignac Continuous Positive Airway Pressure Ventilation on PaO2 and PaO2/FiO2 Ratio Immediately After Extubation in Morbidly Obese Patients Undergoing Bariatric Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Difference in mean PaO2/FiO2 ratio values after surgery
研究概览
简要总结
The purpose of this study is to determine if the application of Boussignac continuous positive airway pressure (CPAP) immediately after extubation improves PaO2 and PaO2/FiO2 ratio in morbidly obese patients undergoing gastric bypass surgery .
详细描述
Background: In 2010, the prevalence of obesity in individuals above 15 years old in Portugal was 15.5% for males and 17.7% for females. .In this country bariatric surgery has increased significantly playing an important role in the treatment of individuals with BMI ≥ 40 kg/m2 or less than 35 kg/m2 in the presence of comorbidities.
Morbid obesity has a negative impact in the respiratory physiology and is associated with a decreased compliance of the lung and chest wall, increased airway resistance, decreased respiratory muscle strength, increased work of breathing, worsening of ventilation / perfusion ratio and postoperative hypoxemia. General anesthesia and surgery in these patients will maximize these physiologic alterations.
Ahmad et al. (2008) found that morbid obesity per se, regardless of the presence of obstructive sleep apnea was associated with increased risk of desaturation in the first 24h of the postoperative period.
Gaszynski et al. (2007) found that the use of Boussignac CPAP in the postoperative period of patients undergoing bariatric surgery improved oxygenation. However, it was used capillary blood gas analysis not arterial blood and the FiO2 was different between groups.
More recently, in 2011, Wong et al. investigated the effect of Boussignac CPAP versus Venturi mask in the first one hour after bariatric surgery, measuring the PaO2 / FiO2 ratio at 1 hour and 2 hours of the postoperative period. The group maintained with CPAP showed better results. There were no differences between the two groups for FEV1 and FVC. The study does not reveal, however, the analgesic protocol used postoperatively or the patient's position during the spirometric measurements. These variables could be possible confounders. The PaO2 absolute value was not evaluated because of the different FiO2 between patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age between 18 and 65 years of age
- •Morbidly obese with a body mass index > 35 kg/m2
- •Laparoscopic gastric bypass
排除标准
- •Patient refusal
- •American Society of Anesthesiologists' (ASA) class IV
- •Lung parenchyma disease
- •Chronic Obstructive Pulmonary Disease
- •Moderate to severe asthma
- •Pre-existing cardiac failure (above class II in the New York Heart Association (NYHA) classification)
- •Estimated pulmonary artery pressure ≥35mmHg
- •Hemoglobin concentration ([Hgb]) less than 7 g / dL
- •Need for invasive ventilation during preoperative immediate post-extubation defined in the preoperative period
- •Patients with obstructive sleep apnea previously treated with CPAP
- •Severe psychiatric disorder
- •Language barrier
结局指标
主要结局
Difference in mean PaO2/FiO2 ratio values after surgery
时间窗: 24 hours
Arterial blood samples for blood gas analysis are collected at 1 hour, 2 hours and 24 hours post-extubation. The differences in the mean values of PaO2/FiO2 ratio are registered and analysed.
Difference in mean PaO2 values after surgery
时间窗: 24 hours
Arterial blood samples for blood gas analysis are collected at 1 hour, 2 hours and 24 hours post-extubation. The differences in the mean values of PaO2 are registered and analysed.
次要结局
- Difference in mean FEV 1 and FVC values(24 hours)
研究者
Joana Alexandra Carvalho Guimarães
MD
Centro Hospitalar do Porto