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Clinical Trials/NCT02386683
NCT02386683
Completed
Not Applicable

Intraoperative Lung-Protective Ventilation in Neurosurgery

Capital Medical University1 site in 1 country360 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventilator-induced Lung Injury
Sponsor
Capital Medical University
Enrollment
360
Locations
1
Primary Endpoint
Postoperative pulmonary complications
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
November 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Capital Medical University
Responsible Party
Principal Investigator
Principal Investigator

Wei Zhang

attending doctor

Capital Medical University

Eligibility Criteria

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)

Study Sites (1)

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