Ventilator-induced Lung Injury
Conditions
Keywords
Protective mechanical ventilation, ventilator-induced lung injury, neurosurgery
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.
Interventions
mechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia
Sponsors
Beijing Tiantan Hospital
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. \> 40 years ,and \< 80 years 2. Scheduled for neurosurgery 3. After informed consent has been obtained 4. With an expected duration of ≥ 4 hours 5. preoperative risk index for pulmonary complications≥ 2 6. Glasgow Coma Scale \>8
Exclusion criteria
1. Mechanical ventilation of \> 1 hour within the last 2 weeks before surgery 2. Body mass index ≥ 35 kg/m2 3. Acute respiratory failure (pneumonia, acute lung injury or acute respiratory distress syndrome) 4. Emergency surgery 5. Severe cardiac disease 6. Progressive neuromuscular illness 7. Pregnancy 8. Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The postoperative complications within 30 days | 30 days after surgery | Surgical complications，Systematic complications; Septic shock， Death |
| Postoperative hypoxemia | 7 days after surgery | PaO2 less than 60 mmHg, SpO2 less than 90%; PaO2 /FiO2 less than 300. |
| Peripheral blood inflammatory response indicators | 1 day after surgery | interleukin 6, tumor necrosis factor TNF-α. |
| Postoperative antibiotic usage | 30 days after surgery | antibiotic dose |
| Intraoperative brain relaxation. | 1 day undergonging surgery | using a four-point scale: 1, completely relaxed; 2, satisfactorily relaxed; 3, firm brain; 4, bulging brain; |
| Unanticipated ICU treatment. | 30 days after surgery | Unanticipated ICU treatment. |
| ICU stay and length of hospital stay | 30 days after surgery | ICU stay and length of hospital stay |
| All cause of mortality at 30 days | 30 days after surgery | mortality |
| Cost analysis | 30 days after surgery | Data of total non-operative costs, costs per day. |
| 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 |
Countries
China
Outcome results
None listed