Clinical trial NCT02386683: Intraoperative Lung-Protective Ventilation in Neurosurgery
Official title: Intraoperative Lung-Protective Ventilation in Neurosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-induced Lung Injury
Keywords: Protective mechanical ventilation
ventilator-induced lung injury
neurosurgery
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2015-03-12
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Intraoperative brain relaxation.
timeFrame: 1 day undergonging surgery
measure: The postoperative complications within 30 days
timeFrame: 30 days after surgery
measure: Postoperative hypoxemia
timeFrame: 7 days after surgery
measure: Peripheral blood inflammatory response indicators
timeFrame: 1 day after surgery
measure: Postoperative antibiotic usage
timeFrame: 30 days after surgery
measure: Postoperative pulmonary complications
timeFrame: 30 days after surgery
measure: Unanticipated ICU treatment.
timeFrame: 30 days after surgery
measure: ICU stay and length of hospital stay
timeFrame: 30 days after surgery
measure: All cause of mortality at 30 days
timeFrame: 30 days after surgery
measure: Cost analysis
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Department of Anesthesiology, Beijing Tiantan Hospital， Capital Medical University
name: Ruquan Han, MD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology, Beijing Tiantan Hospital， Capital Medical University
name: liyong Zhang, MD
role: STUDY_DIRECTOR
References:
citation: Zhang L, Xiong W, Peng Y, Zhang W, Han R. The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial. Trials. 2018 Feb 2;19(1):85. doi: 10.1186/s13063-018-2447-4.