An interventional study of lung-protective ventilation in Ventilator-induced Lung Injury, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Capital Medical University · Not applicable, Interventional, and Prevention
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.
100 studies on the registry are indexed under Ventilator-Induced Lung Injury; 35 are open to participants now.
This study's enrollment of 360 is above the median of 38 across 60 interventional studies indexed under Ventilator-Induced Lung Injury.
Browse Ventilator-Induced Lung Injury studies →Capital Medical University is the lead sponsor of 293 studies on the registry; 91 are open to participants now.
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Exclusion Criteria:
lung-protective ventilation applied in anesthesia
Other: lung-protective ventilation
traditional ventilation applied in anesthesia
mechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia
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
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
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: 30 days after surgery
Unanticipated ICU treatment.
Unanticipated ICU treatment.
Time frame: 30 days after surgery
ICU stay and length of hospital stay
ICU stay and length of hospital stay
Time frame: 30 days after surgery
All cause of mortality at 30 days
mortality
Time frame: 30 days after surgery
Cost analysis
Data of total non-operative costs, costs per day.
Time frame: 30 days after surgery
Plan to share: No
Ran from Oct 2015 to primary completion in Mar 2020, 53 months.
Of 36 interventional studies with no phase under Ventilator-Induced Lung Injury, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's 53 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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