Intraoperative Lung-Protective Ventilation in Neurosurgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intraoperative Lung-Protective Ventilation in Neurosurgery

Conditions
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Ventilator-induced Lung Injury

Intervention / Treatment
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* Other: lung-protective ventilation


Participation Criteria
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Eligibility Criteria
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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 Pregnancy Refusal to participate

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group L<br>lung-protective ventilation applied in anesthesia | Other: lung-protective ventilation<br>* mechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia<br>|
| No Intervention: Group T<br>traditional ventilation applied in anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protective mechanical ventilation, ventilator-induced lung injury, neurosurgery