Intraoperative Lung-Protective Ventilation in Neurosurgery

Capital Medical University360 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

360

Conditions

Ventilator-induced Lung Injury

Interventions

lung-protective ventilationOTHER

mechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Time frame: 7 days after surgery

Secondary Outcomes

Intraoperative brain relaxation.

using a four-point scale: 1, completely relaxed; 2, satisfactorily relaxed; 3, firm brain; 4, bulging brain;

Time frame: 1 day undergonging surgery

The postoperative complications within 30 days

Surgical complications，Systematic complications; Septic shock， Death

Time frame: 30 days after surgery

Postoperative hypoxemia

PaO2 less than 60 mmHg, SpO2 less than 90%; PaO2 /FiO2 less than 300.

Time frame: 7 days after surgery

Peripheral blood inflammatory response indicators

interleukin 6, tumor necrosis factor TNF-α.

Time frame: 1 day after surgery

Postoperative antibiotic usage

antibiotic dose

Time frame: 30 days after surgery

Postoperative pulmonary complications

Data from ClinicalTrials.gov

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