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.

Study Overview

• Status: Completed
• Conditions: Ventilator-induced Lung Injury
• Intervention / Treatment: Other: lung-protective 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.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Zhang, MD; Phone Number: 008613810045210; Email: zhangliu1982@sina.com
• Study Contact Backup: Name: Wei Xiong, MD; Phone Number: 008601067096658; Email: gydxiongwei@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: Beijing Tiantan Hospital
• Investigators: 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 and helpful links

General Publications

• Zhang L, Xiong W, Peng Y, Zhang W, Han R. The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial. Trials. 2018 Feb 2;19(1):85. doi: 10.1186/s13063-018-2447-4.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: October 18, 2014
• First Submitted That Met QC Criteria: March 6, 2015
• First Posted (Estimated): March 12, 2015

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: neurosurgery; ventilator-induced lung injury; Protective mechanical ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: kY2014-031-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO