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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
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The purpose of this study is to explore the effectiveness of lung-protective ventilation during general anesthesia for neurosurgical procedures on postoperative pulmonary outcome, compared with traditional ventilation.
After screened for preoperative risk classification of postoperative respiratory complications,360 patients undergoing elective neurosurgery are randomly assigned to two groups, lung-protective ventilation (L) and traditional ventilation(T).Patients are mechanical ventilated with either a tidal volume of 10-12 ml/kg ideal body weight (IBW,T) or 6-8ml/kg IBW with 6-8 cm H2O PEEP(L),both with recruitment maneuver (RM).Each RM consists of applying a continuous positive airway pressure of 30 cmH2O for 30 seconds. Postoperative pulmonary complications are compared between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Active Comparator | lung-protective ventilation applied in anesthesia |
|
| Group T | No Intervention | traditional ventilation applied in anesthesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lung-protective ventilation | Other | mechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pulmonary complications | modified Clinical Pulmonary Infection Score (mCPIS):Temperature,Blood leukocytes,Tracheal secretions,Oxygenation Pao2/Fio2,Chest radiograph; Grade scale for postoperative pulmonary complications:Grade 0 representing the absence of any pulmonary complication and grades 1 through 4 representing successively the worse forms of complications | 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative brain relaxation. | using a four-point scale: 1, completely relaxed; 2, satisfactorily relaxed; 3, firm brain; 4, bulging brain; | 1 day undergonging surgery |
| The postoperative complications within 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruquan Han, MD | Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University | Study Chair |
| liyong Zhang, MD | Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29394907 | Derived | Zhang L, Xiong W, Peng Y, Zhang W, Han R. The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial. Trials. 2018 Feb 2;19(1):85. doi: 10.1186/s13063-018-2447-4. |
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| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Surgical complications,Systematic complications; Septic shock, Death
| 30 days after surgery |
| Postoperative hypoxemia | PaO2 less than 60 mmHg, SpO2 less than 90%; PaO2 /FiO2 less than 300. | 7 days after surgery |
| Peripheral blood inflammatory response indicators | interleukin 6, tumor necrosis factor TNF-α. | 1 day after surgery |
| Postoperative antibiotic usage | antibiotic dose | 30 days after surgery |
| Postoperative pulmonary complications | modified Clinical Pulmonary Infection Score (mCPIS):Temperature,Blood leukocytes,Tracheal secretions,Oxygenation Pao2/Fio2,Chest radiograph; Grade scale for postoperative pulmonary complications:Grade 0 representing the absence of any pulmonary complication and grades 1 through 4 representing successively the worse forms of complications | 30 days after surgery |
| Unanticipated ICU treatment. | Unanticipated ICU treatment. | 30 days after surgery |
| ICU stay and length of hospital stay | ICU stay and length of hospital stay | 30 days after surgery |
| All cause of mortality at 30 days | mortality | 30 days after surgery |
| Cost analysis | Data of total non-operative costs, costs per day. | 30 days after surgery |