Intraoperative Lung-Protective Ventilation in Neurosurgery
- Conditions
- Ventilator-induced Lung Injury
- Interventions
- Other: lung-protective ventilation
- Registration Number
- NCT02386683
- Lead Sponsor
- Capital Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- > 40 years ,and < 80 years
- Scheduled for neurosurgery
- After informed consent has been obtained
- With an expected duration of ≥ 4 hours
- preoperative risk index for pulmonary complications≥ 2
- Glasgow Coma Scale >8
- Mechanical ventilation of > 1 hour within the last 2 weeks before surgery
- Body mass index ≥ 35 kg/m2
- Acute respiratory failure (pneumonia, acute lung injury or acute respiratory distress syndrome)
- Emergency surgery
- Severe cardiac disease
- Progressive neuromuscular illness
- Pregnancy
- Refusal to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group L lung-protective ventilation lung-protective ventilation applied in anesthesia
- Primary Outcome Measures
Name Time Method Postoperative pulmonary complications 7 days after surgery 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
- Secondary Outcome Measures
Name Time Method The postoperative complications within 30 days 30 days after surgery Surgical complications，Systematic complications; Septic shock， Death
Intraoperative brain relaxation. 1 day undergonging surgery using a four-point scale: 1, completely relaxed; 2, satisfactorily relaxed; 3, firm brain; 4, bulging brain;
Postoperative antibiotic usage 30 days after surgery antibiotic dose
Postoperative hypoxemia 7 days after surgery PaO2 less than 60 mmHg, SpO2 less than 90%; PaO2 /FiO2 less than 300.
Unanticipated ICU treatment. 30 days after surgery Unanticipated ICU treatment.
Peripheral blood inflammatory response indicators 1 day after surgery interleukin 6, tumor necrosis factor TNF-α.
All cause of mortality at 30 days 30 days after surgery mortality
Postoperative pulmonary complications 30 days after surgery 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
ICU stay and length of hospital stay 30 days after surgery ICU stay and length of hospital stay
Cost analysis 30 days after surgery Data of total non-operative costs, costs per day.
Trial Locations
- Locations (1)
Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China