Skip to main content
. 2017 Jul 13;2017(7):CD004104. doi: 10.1002/14651858.CD004104.pub4

Zhou 2001.

Methods Country: China
Design: Randomised controlled trial, but no information about randomisation method or allocation concealment provided
Study site: Single centre at the Second Xiangya Hospital, Central South University, Changsha, China
Setting: Not stated whether conducted in ICU or on ward
Methods of analysis: Means for before and after intervention were compared by t‐test. Chi2 analysis was used for differences in rates of intubation between 2 groups
Aim: To observe effects of NIV on gas exchange and on patients’ transformation, and to evaluate clinical value
Participants Eligible for study: Not mentioned
Recruited: Total of 60 participants with COPD were randomised to 2 groups: 30 to NIV group and 30 to usual care group. No differences in baseline characteristics between 2 groups; P > 0.05
Completed: Unsure, not mentioned in text or table. Presumed all 60 participants completed study. Intention‐to‐treat data were analysed with 30 participants on each arm
Age: NIV group: 63.5 ± 9.1 years. Usual care group: 64.3 ± 9.4 years
Gender: NIV group: 22 male and 8 female. Usual care group: 24 male and 6 female
Criteria used to define COPD: No details available
Inclusion criteria: Patients with COPD admitted to hospital with respiratory failure of PaCO2 > 50 mmHg
Exclusion criteria: Patients who were hypotensive with SBP < 90 mmHg, with cardiac arrhythmias, or comatose
Interventions Intervention description: NIV was provided via Respironics, Inc. BiPAP ST‐D model with nasal/face mask. S/T mode was selected with IPAP 8 to 14 cmH2O , EPAP 2 to 6 cmH2O. All participants also received oxygen FiO2 22% to 33%, antibiotics, mucolytics, bronchodilator, glucocorticoids, and nutrients that required improving treatments and respiratory stimulants for patients with pulmonary encephalopathy
Control description: Oxygen FiO2 22% to 33%, antibiotics, mucolytics, bronchodilator, glucocorticoids, and nutrients that required improving treatments and respiratory stimulants for patients with pulmonary encephalopathy
Duration of intervention: 2 days with ≥ 4 hours of NIV each day
Intervention delivery by: Not reported in text
Outcomes Method of outcome data collection: Data were collected at baseline and throughout hospital stay
Prespecified primary outcome: Protocol not available. In text outcomes: ABG, heart rate and respiratory rate changes
Prespecified secondary outcome: Protocol not available. In text outcome: Intubation rate
Validation: ABG, HR, RR
Follow‐up period: Throughout admission, until discharged or endpoint reached
Number of follow‐up periods reported on during study: Not mentioned in text
Indications for intubation: PaCO2 > 70 mmHg or PaCO2 increased by 5 to 10 mmHg, pH decreased by 0.05 to 0.1, reduced GCS or PaO2 < 45 mmHg
Notes ABGs and vital signs changes were compared from baseline to 2 days post treatment. No data available 1 hour post NIV. Hence data not included in meta‐analysis
Paper written in Chinese, with limited translation by translator. Attempts to contact study authors for more information were met with no reply
Funder: Not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not mentioned in the paper; stated only that participants were randomly assigned to control vs intervention group
Allocation concealment (selection bias) Unclear risk Not mentioned in the paper; stated only that participants were randomly assigned to control vs intervention group
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No sham NIV used
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not mentioned in paper who delivered NIV and who collected data
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information available
Selective reporting (reporting bias) Unclear risk Insufficient information available
Imbalance of outcome measures at baseline 
 All outcomes Unclear risk Insufficient information available
Comparability of intervention and control group characteristics at baseline Unclear risk Insufficient information available
Protection against contamination 
 All outcomes Unclear risk Insufficient information available
Selective recruitment of participants Unclear risk Insufficient information available
Other bias Unclear risk Insufficient information reported in paper. Attempts to contact study authors were met with no response

ABG: Arterial blood gases; AECOPD: Acute exacerbation of chronic obstructive pulmonary disease; AHRF: Acute hypercapnic respiratory failure; APO: Acute pulmonary oedema; BiPAP: bi‐level positive airway pressure; BMI: Body mass index; BP: blood pressure; CHF: Congestive heart failure; cmH2O: centimetres of water; COPD: Chronic obstructive pulmonary disease; CXR: chest x‐ray; DIC: disseminated intravascular coagulation; ECG: electrocardiography; ED: Emergency department; EMG: electromyography; EPAP: Expiratory positive pressure; FEV1: Forced expiratory volume in one second; FiO2: Fraction of inspired oxygen; GCS: Glasgow Coma Scale; GI: gastrointestinal; HR: Heart rate; ICU: Intensive care unit; IV: intravenously; IPAP: Inspiratory positive pressure; LOS: length of stay; mmHg: millimetres of mercury; NIPPV: non‐invasive positive pressure ventilation; NIV: Non‐invasive ventilation; PE: Pulmonary embolism; PaO2: Partial pressure of oxygen (arterial); PaCO2: Partial pressure of carbon dioxide (arterial); PEEP: Positive expiratory end pressure; PFT: pulmonary function test; PS: pressure support; RR: Respiratory rate; SaO2: arterial oxygen saturation; SAPS: simplified acute physiology score; SCM: sternocleidomastoid; SD: Standard deviation; SE: standard error; SpO2: peripheral oxygen saturation; SPSS: Statistical Package for the Social Sciences; TV: tidal volume; VAS: Visual analogue scale.