Background
Methods/design
Study settings
Site ID | Site name |
---|---|
1 | Ren Ji Hospital (East), affiliated to Shanghai Jiao Tong University School of Medicine |
2 | Fudan University Shanghai Cancer Center |
3 | Shanghai Changzheng Hospital |
4 | Shanghai First Maternity and Infant Hospital |
5 | Huadong Hospital, Fudan University |
6 | West China Hospital, Sichuan University |
7 | Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine |
8 | Shanghai Jiading District Central Hospital |
9 | Shanghai Pudong District Central Hospital |
10 | Shanghai Huangpu District Central Hospital |
11 | Shanghai Fengxian District Central Hospital |
12 | Ren Ji Hospital (West), affiliated to Shanghai Jiao Tong University School of Medicine |
13 | People’s Hospital of Pudong New District, Shanghai |
14 | Ren Ji Hospital (South), affiliated to Shanghai Jiao Tong University School of Medicine |
15 | First Affiliated Hospital of Wenzhou Medical University, Zhejiang Province |
16 | The Second People’s Hospital of Wuxi, Jiangsu Province |
17 | First Affiliated Hospital of Xiamen University, School of Medicine |
Inclusion and exclusion criteria
Ethics issues
Blinding, randomization, and allocation concealment
Independent risk factors | Risk score |
---|---|
Age > 70 years | 1 |
Cough and sputum production | 1 |
Diabetes | 1 |
Smoker (or patient quit within the past 6 months) | 1 |
COPD | 1 |
BMI > 27 kg/m2 | 1 |
FEV1 < 80% and FEV1/FVC < 70% | 2 |
Intervention
Primary outcomes
Grading | Definition |
---|---|
0 | No pulmonary complications |
1 | Any one of the following: cough, minor lung atelectasis (no obvious cause), dyspnea (no obvious cause) |
2 | Cough and sputum production (no obvious cause), bronchospasm (new-onset asthma or exacerbation of existing asthma that requires treatment), hypoxemia (SpO2 < 90% or PaO2 < 60 mmHg while breathing air), atelectasis (diagnosed by radiography or abnormal pulmonary sign with T > 37.5), hypercapnia (temporary or requires treatment; caused by medication or over-ventilation) |
3 | Pleural effusion (that requires drainage), suspected pneumonia (indicated by radiography, with or without microbiologic findings), diagnosed pneumonia (diagnosed based on the combination of radiology finding and microbiology evidence such as Gram staining or culture), pneumothorax (suggested by X-ray: observation of a lucent gas space devoid of pulmonary vessels between visceral pleura and the parietal pleura or symptoms of dyspnea, chest pain, irritating cough), noninvasive or invasive mechanical ventilation < 48 h |
4 | Respiratory failure (that requires noninvasive or invasive mechanical ventilation for > 48 h) |
Complications | Diagnostic criteria |
---|---|
Pneumonia | X-ray finding of a new or progressive pulmonary infiltration and meeting 2 of the following 3 indications: |
(1) Cough, exacerbation of dyspnea or purulent sputum | |
(2) Body temperature above 38 °C or under 36 °C | |
(3) WBC > 12,000 or < 4000/μL | |
Atelectasis | Mainly based on X-ray findings as follows: |
Lung collapse | |
Compensatory hyperinflation of adjacent ipsilateral lung tissue | |
Wedge- or linear-shaped opacities | |
Shifting of mediastinum | |
Diaphragm move towards the collapse | |
Pleural effusion | X-ray finding of obscure or disappearance of costophrenic angle, obscured ipsilateral diaphragm |
SIRS | (1) Core body temperature > 38 °C or < 36 °C |
(2) HR > 90 bpm, in cases of atrial arrhythmia, ventricular rate > 90 bpm; exclude when used medications that may affect heart rate | |
(3) RR > 20 bpm, or PaCO2 < 32 mmHg (4.2 kPa), or urgent mechanical ventilation used | |
(4) WBC > 12,000 or < 4000/μL | |
Sepsis | (1) Positive microbiologic culture from blood, or definite tissue infection, presence of abscess |
(2) Meets at least 2 SIRS definitions | |
ALI/ARDS | (1) Lung injury of acute onset (within 1 week or progressive) |
(2) Hypoxemia, PaO2/FiO2 ≤ 300/200 mmHg | |
(3) X-ray showing obscured bilateral lobes which cannot be explained by effusion, atelectasis, or nodules | |
(4) Respiratory failure that cannot be explained by heart failure or hypervolemia |