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Trial record 1 of 1 for:    NCT02386683
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Intraoperative Lung-Protective Ventilation in Neurosurgery

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ClinicalTrials.gov Identifier: NCT02386683
Recruitment Status : Recruiting
First Posted : March 12, 2015
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Wei Zhang, Capital Medical University

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.

Condition or disease Intervention/treatment Phase
Ventilator-induced Lung Injury Other: lung-protective ventilation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Intraoperative Lung-Protective Ventilation in Neurosurgery
Actual Study Start Date : October 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
Active Comparator: Group L
lung-protective ventilation applied in anesthesia
Other: lung-protective ventilation
mechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia

No Intervention: Group T
traditional ventilation applied in anesthesia



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Intraoperative brain relaxation. [ Time Frame: 1 day undergonging surgery ]
    using a four-point scale: 1, completely relaxed; 2, satisfactorily relaxed; 3, firm brain; 4, bulging brain;

  2. The postoperative complications within 30 days [ Time Frame: 30 days after surgery ]
    Surgical complications,Systematic complications; Septic shock, Death

  3. Postoperative hypoxemia [ Time Frame: 7 days after surgery ]
    PaO2 less than 60 mmHg, SpO2 less than 90%; PaO2 /FiO2 less than 300.

  4. Peripheral blood inflammatory response indicators [ Time Frame: 1 day after surgery ]
    interleukin 6, tumor necrosis factor TNF-α.

  5. Postoperative antibiotic usage [ Time Frame: 30 days after surgery ]
    antibiotic dose

  6. Postoperative pulmonary complications [ Time Frame: 30 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

  7. Unanticipated ICU treatment. [ Time Frame: 30 days after surgery ]
    Unanticipated ICU treatment.

  8. ICU stay and length of hospital stay [ Time Frame: 30 days after surgery ]
    ICU stay and length of hospital stay

  9. All cause of mortality at 30 days [ Time Frame: 30 days after surgery ]
    mortality

  10. Cost analysis [ Time Frame: 30 days after surgery ]
    Data of total non-operative costs, costs per day.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386683


Contacts
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Contact: Wei Zhang, MD 008613810045210 zhangliu1982@sina.com
Contact: Wei Xiong, MD 008601067096658 gydxiongwei@sina.com

Locations
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China, Beijing
Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Wei Xiong, MD    8610-67096658    gydxiongwei@sina.com   
Contact: Wei Zhang, MD    8610-67096658    fancyzhang1982@hotmail.com   
Sponsors and Collaborators
Capital Medical University
Beijing Tiantan Hospital
Investigators
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Study Chair: Ruquan Han, MD Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University
Study Director: liyong Zhang, MD Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wei Zhang, attending doctor, Capital Medical University
ClinicalTrials.gov Identifier: NCT02386683     History of Changes
Other Study ID Numbers: kY2014-031-02
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wei Zhang, Capital Medical University:
Protective mechanical ventilation
ventilator-induced lung injury
neurosurgery

Additional relevant MeSH terms:
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Lung Injury
Ventilator-Induced Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries