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Completed

NCT Number: NCT02386683

Intraoperative Lung-Protective Ventilation in Neurosurgery

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.

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Key information

Conditions

Ventilator-Induced Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Pregnancy
  • Refusal to participate

Treatment and study plan

lung-protective ventilation

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Beijing Tiantan Hospital

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2015
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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