Impact of High-Intensity-NIV Vs Low-intensity-NIV on Subjective Tolerance Amomg Patients with AECOPD : a Randomised Cross-over Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- NPPV subjective tolerance
研究概览
简要总结
To determine whether high-intensity NPPV, compared with low-intensity NPPV, could have an effect on the subjective tolerance in patients with an AECOPD and hypercapnia.
详细描述
To evaluate the subjective tolerance of high-intensity NPPV and low-intensity NPPV patients in a conscious state by two questionnaire surveys; To assess tolerance of high-intensity NPPV and low-intensity NPPV patients patient in sleeping status by PSG monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double
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
- •AECOPD confirmed by the 2019 criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD);
- •Arterial pH <7.35 and PaCO2 >45 mmHg at screening entry;
- •PaCO2 >45 mmHg after a 6-hour trial of low-intensity NPPV.
排除标准
- •Age <18 years
- •Excessive respiratory secretions with weak cough
- •Upper airway obstruction
- •Recent oral, facial, or cranial trauma or surgery
- •Recent gastric or esophageal surgery
- •Presence of restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, or severe abdominal distension)
- •Active upper gastrointestinal bleeding
- •Cardiac or respiratory arrest
- •Arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) <100 mmHg
- •Pneumothorax
- •Obvious emphysematous bullae confirmed by chest CT scan
- •Ventricular arrhythmia or myocardial ischemia
- •Severe hemodynamic instability (mean arterial pressure <65 mmHg)
- •Severe metabolic acidosis (pH <7.20 and bicarbonate <22 mmol/L)
- •Refusal to receive NPPV or give informed consent
- •Prior endotracheal intubation or tracheostomy during the current hospitalization
- •A do-not-intubate order
结局指标
主要结局
NPPV subjective tolerance
时间窗: From randomization to 2 days after randomization
NPPV subjective tolerance is mainly evaluated through two questionnaire surveys. Questionnaire survey 1 includes 19 questions, including bloating , appetite, thirst, dryness of the mouth and nose, conjunctivitis, facial tenderness, fear, airflow shock, mask tolerance, ear pain, noise, overall tolerance of NPPV, willingness to use NPPV, confidence of using NPPV, breathless relief score, sleep quality, drowsiness in day, physical strength, and mood. Questionnaire survey 2 mainly evaluates patients' feelings of using NPPV under different emotional states, feelings of using NPPV under different physical states, and feelings of using NPPV in daily life states. Each question is scored from 0 to 100 points. The higher scores indicate better positive feedback.
次要结局
- Effects of NPPV on sleep quality(From randomization to 2 days after randomization)