Comparison the Effectiveness of Postoperative Incentive Spirometry and Noninvasive Mechanical Ventilation in Patients Following Craniotomy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline forced expiratory volume at one second (FEV1) % predicted (no unit)
研究概览
简要总结
This study will compare the effectiveness of postoperative incentive spirometry and noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients. Patients were randomized into a control group (G-K, n:20), an IS group (G-IS, n:20) and a CPAP (continuous positive airway pressure) group (G-CPAP, n:20)
详细描述
This study will compare the effectiveness of postoperative incentive spirometry and noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients. Patients were randomized into a control group (G-K, n:20), an IS group (G-IS, n:20) and a CPAP (continuous positive airway pressure) group (G-CPAP, n:20).
The investigators included male or female, between 18 and 60 years old, American Society of Anesthesiologists score 1, 2 patients in this study. The investigator excluded patients with significant cardiopulmonary disease like myocardial infarction, obstructive or restrictive pulmonary disease, liver or kidney failure, chest wall deformities, postoperative lack of cooperation from this study. In postoperatively, control group will take 4lt/min oxygen with Plasti-med oxygen therapy mask for 6 hours, IS group will carry out Plasti-med TRIFLO 5 min per hour for 6 hours, CPAP group will carry out 10 cmH2O noninvasive continuous positive airway pressure with BIPAP VISION 5 min per hour for 6 hours. Lung functions and arterial blood gas analysis will be recorded preoperative baseline, postoperative 1st, 6th and 24th hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists score 1, 2 patients
排除标准
- •Patients with significant cardiopulmonary disease like myocardial infarction, obstructive or restrictive pulmonary disease, liver or kidney failure, chest wall deformities, postoperative lack of cooperation
研究组 & 干预措施
control group
take 4lt/min oxygen with Plasti-med oxygen therapy mask
干预措施: Plasti-med oxygen therapy mask (Device)
IS group
in postoperatively, patients will carry out Plasti-med TRIFLO 5 min per hour for 6 hours.
干预措施: Plasti-med TRIFLO (Device)
CPAP group
in postoperatively, patients will carry out 10 cmH2O noninvasive continuous positive airway pressure with BIPAP VISION 5 min per hour for 6 hours.
干预措施: BIPAP VISION (Device)
结局指标
主要结局
Change from baseline forced expiratory volume at one second (FEV1) % predicted (no unit)
时间窗: preoperative baseline, postoperative 1st, 6th and 24th hours
The investigators will use Spirolab 3 COLOUR LCD device for measurement.
次要结局
- Change from baseline FEV1/FVC ratio (no units)(preoperative baseline, postoperative 1st, 6th and 24th hours)
- Change from baseline partial arterial carbondioxide pressure (PaCO2) (mmHg)(preoperative baseline, postoperative 1st, 6th and 24th hours)
- Change from baseline forced vital capacity (FVC) % predicted (no unit)(preoperative baseline, postoperative 1st, 6th and 24th hours)
- Change from baseline base excess (BE) (mmol/L)(preoperative baseline, postoperative 1st, 6th and 24th hours)
- Change from baseline partial arterial oxygen pressure( PaO2) (mmHg)(preoperative baseline, postoperative 1st, 6th and 24th hours)
- Change from baseline power of hydrogen (pH)(preoperative baseline, postoperative 1st, 6th and 24th hours)
- Change from baseline bicarbonate (HCO3) (mmol/L)(preoperative baseline, postoperative 1st, 6th and 24th hours)
- Change from baseline arterial oxygen saturation (SaO2) (%)(preoperative baseline, postoperative 1st, 6th and 24th hours)
- Change from baseline PaO2/FiO2 ratio (no units)(preoperative baseline, postoperative 1st, 6th and 24th hours)
研究者
HULYA KAHRAMAN SAH
MD
Istanbul University