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Intraoperative Lung-Protective Ventilation in Neurosurgery

Primary Purpose

Ventilator-induced Lung Injury

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
lung-protective ventilation
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator-induced Lung Injury focused on measuring Protective mechanical ventilation, ventilator-induced lung injury, neurosurgery

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group L

Group T

Arm Description

lung-protective ventilation applied in anesthesia

traditional ventilation applied in anesthesia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 18, 2014
Last Updated
August 28, 2023
Sponsor
Capital Medical University
Collaborators
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02386683
Brief Title
Intraoperative Lung-Protective Ventilation in Neurosurgery
Official Title
Intraoperative Lung-Protective Ventilation in Neurosurgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
Collaborators
Beijing Tiantan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-induced Lung Injury
Keywords
Protective mechanical ventilation, ventilator-induced lung injury, neurosurgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group L
Arm Type
Active Comparator
Arm Description
lung-protective ventilation applied in anesthesia
Arm Title
Group T
Arm Type
No Intervention
Arm Description
traditional ventilation applied in anesthesia
Intervention Type
Other
Intervention Name(s)
lung-protective ventilation
Intervention Description
mechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia
Primary Outcome Measure Information:
Title
Postoperative pulmonary complications
Description
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
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
Intraoperative brain relaxation.
Description
using a four-point scale: 1, completely relaxed; 2, satisfactorily relaxed; 3, firm brain; 4, bulging brain;
Time Frame
1 day undergonging surgery
Title
The postoperative complications within 30 days
Description
Surgical complications，Systematic complications; Septic shock， Death
Time Frame
30 days after surgery
Title
Postoperative hypoxemia
Description
PaO2 less than 60 mmHg, SpO2 less than 90%; PaO2 /FiO2 less than 300.
Time Frame
7 days after surgery
Title
Peripheral blood inflammatory response indicators
Description
interleukin 6, tumor necrosis factor TNF-α.
Time Frame
1 day after surgery
Title
Postoperative antibiotic usage
Description
antibiotic dose
Time Frame
30 days after surgery
Title
Postoperative pulmonary complications
Description
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
Time Frame
30 days after surgery
Title
Unanticipated ICU treatment.
Description
Unanticipated ICU treatment.
Time Frame
30 days after surgery
Title
ICU stay and length of hospital stay
Description
ICU stay and length of hospital stay
Time Frame
30 days after surgery
Title
All cause of mortality at 30 days
Description
mortality
Time Frame
30 days after surgery
Title
Cost analysis
Description
Data of total non-operative costs, costs per day.
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, MD
Organizational Affiliation
Department of Anesthesiology, Beijing Tiantan Hospital， Capital Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
liyong Zhang, MD
Organizational Affiliation
Department of Anesthesiology, Beijing Tiantan Hospital， Capital Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29394907
Citation
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.
Results Reference
derived

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Intraoperative Lung-Protective Ventilation in Neurosurgery

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