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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02386683
Other study ID # kY2014-031-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date November 2020

Study information

Verified date August 2023
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date November 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Capital Medical University Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 7 days after surgery
Secondary Intraoperative brain relaxation. using a four-point scale: 1, completely relaxed; 2, satisfactorily relaxed; 3, firm brain; 4, bulging brain; 1 day undergonging surgery
Secondary The postoperative complications within 30 days Surgical complications,Systematic complications; Septic shock, Death 30 days after surgery
Secondary Postoperative hypoxemia PaO2 less than 60 mmHg, SpO2 less than 90%; PaO2 /FiO2 less than 300. 7 days after surgery
Secondary Peripheral blood inflammatory response indicators interleukin 6, tumor necrosis factor TNF-a. 1 day after surgery
Secondary Postoperative antibiotic usage antibiotic dose 30 days after surgery
Secondary 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 30 days after surgery
Secondary Unanticipated ICU treatment. Unanticipated ICU treatment. 30 days after surgery
Secondary ICU stay and length of hospital stay ICU stay and length of hospital stay 30 days after surgery
Secondary All cause of mortality at 30 days mortality 30 days after surgery
Secondary Cost analysis Data of total non-operative costs, costs per day. 30 days after surgery
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