Intraoperative Lung-Protective Ventilation in Neurosurgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Postoperative pulmonary complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •> 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
Exclusion Criteria
- •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
- •Refusal to participate
Outcomes
Primary Outcomes
Postoperative pulmonary complications
Time Frame: 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 Outcomes
- Intraoperative brain relaxation.(1 day undergonging surgery)
- Postoperative antibiotic usage(30 days after surgery)
- Postoperative hypoxemia(7 days after surgery)
- Unanticipated ICU treatment.(30 days after surgery)
- The postoperative complications within 30 days(30 days after surgery)
- Peripheral blood inflammatory response indicators(1 day after surgery)
- All cause of mortality at 30 days(30 days after surgery)
- Postoperative pulmonary complications(30 days after surgery)
- ICU stay and length of hospital stay(30 days after surgery)
- Cost analysis(30 days after surgery)
Investigators
Wei Zhang
attending doctor
Capital Medical University