Intraoperative Lung-Protective Ventilation in Neurosurgery

Ventilator-induced Lung Injury Clinical Trial

Official title:

Intraoperative Lung-Protective Ventilation in Neurosurgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386683
• Other study ID #: kY2014-031-02
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lung Injury
• Ventilator-Induced Lung Injury

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