High Flow Nasal Oxygen and Acute Left Heart Failure
关键词
抽象
描述
1. The anticipated number of patient subjects will reach 120 in the study. The patient's condition should be informed to his/her next of kin and then agree to signs the informed consent.
2. When passing spontaneous breathing trials and removing tracheal tube, the patients should be divided into two groups by random digital table.
3. Group A/HFNO group: the patients should receive the treatment of high flow nasal oxygen immediately after extubation. The initial flow speed was set at 30L/min and increased at 5L/min in titrated type until the patient feels uncomfortable. The temperature was set at 37℃. The fraction of inspiration O2 was set in accordance with specific condition of patient to insure oxygen saturation more than 95%.
Group B/NIV group: the patients should receive the treatment of non-invasive ventilation immediately after extubation. The initial pressure are set at a lower level (inspiratory pressure: 6-8cmH2O, expiratory pressure: 4cmH2O) and adjusted to a suitable level in 10-20min. The fraction of inspiration O2 was set in accordance with specific condition of patient to insure oxygen saturation more than 95%.
4. The criteria of successful extubation: the patient doesn't require re-intubation within 48 hours after extubation.
The criteria of extubation failure: the patient needs re-intubation and ventilation support within 48 hours after extubation.
5. (1) Investigators should keep a record of these patient's general condition, for instance, age, sex, diagnosis, Apache II score, treatment, etc.(2) Investigators should routinely detect clinical manifestation, ventilation parameters and physiological indices of the recruited patients. Elementary monitoring indicators consist of vital signs, oxygen saturation, ECG, tidal volume, breathing rate, inspiratory pressure, expiratory pressure and blood gas analysis. Blood gas analysis should be evaluated on an average of 12 hours, within the range of 48 hours after extubation.(3) Clinical prognosis of these patients should be recorded, including the rate of weaning failure, re-intubation rate, time for re-intubation, causes of re-intubation, duration of HFNO/HIV, length of ICU stay, hospitalization time and number of death.（4） The data of adverse effect derived from devices applied in the study should be recorded. HFNO group: dry nasal cavity, dry oropharyngeal cavity, dysphagia.HIV group: dry oropharyngeal cavity, skin injury caused by mask oppression, gaseous distention, vomiting, respiratory aspiration, air leak, drying sputum, difficulty in coughing up phlegm and claustrophobia.
日期
| 最后验证: | 06/30/2018 |
| 首次提交: | 07/01/2018 |
| 提交的预估入学人数: | 07/28/2018 |
| 首次发布: | 07/30/2018 |
| 上次提交的更新: | 07/28/2018 |
| 最近更新发布: | 07/30/2018 |
| 实际学习开始日期: | 05/09/2018 |
| 预计主要完成日期: | 06/29/2021 |
| 预计完成日期: | 12/30/2021 |
状况或疾病
干预/治疗
Device: HFNO group/Group A
Device: NIV group/Group B
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: HFNO group/Group A The patients should receive the treatment of high flow nasal oxygen immediately after extubation. | Device: HFNO group/Group A The initial flow speed is set at 30L/min and increases at 5L/min in titrated type until the patient feels uncomfortable. The temperature is set at 37℃. The fraction of inspiration O2 is set in accordance with specific condition of patient to insure oxygen saturation more than 95%. |
| Placebo Comparator: NIV group/Group B The patients should receive the treatment of non-invasive Ventilation immediately after extubation. | Device: NIV group/Group B The values of initial pressure are set at a lower level (inspiratory pressure: 6-8cmH2O, expiratory pressure: 4cmH2O) and adjusted to a suitable level in 10-20min. The fraction of inspiration O2 is set in accordance with specific condition of patient to insure oxygen saturation more than 95%. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - (1) Clinical diagnosis of acute left heart failure - (2) The patient receives invasive ventilation for more than 24 hours - (3) Must pass spontaneous breathing trials - (4) Patient's next of kin agrees to sign the informed consent. Exclusion Criteria: - (1) Chronic Obstructive Pulmonary Disease (COPD) - (2) Disturbance of consciousness - (3)Bulbar paralysis, dysphagia - (4) Facial deformity - (5) Terminal tumor - (6) Neuromuscular disease |
结果
主要结果指标
1. re-intubation rate within 48 hours [48 hours after extubation.]
次要成果指标
1. Mortality [28 days after joining the study.]
2. Hospitalization time [From date of randomization to the day when the patient discharges from any cause, assessed up to three months]
3. The length of ICU stay [From date of randomization to the day when the patient leaves ICU ward, assessed up to three months]
4. blood gas analysis [on an average of 12 hours, within the range of 48 hours after extubation]
