Ventilator-induced Lung InjuryNCT02386683
Intraoperative Lung-Protective Ventilation in Neurosurgery
A study testing lung-protective ventilation in people with Ventilator-induced Lung Injury, run by Capital Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ventilator-induced Lung Injury
- What is being tested?
- lung-protective ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
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.
Read the 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.
- Conditions
- Ventilator-induced Lung Injury
- Being tested
- lung-protective ventilation
- Keywords
- Protective mechanical ventilation, ventilator-induced lung injury, neurosurgery
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung-protective ventilationOther
mechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | lung-protective ventilation applied in anesthesia Receives: Other: lung-protective ventilation |
| Group T | No intervention | traditional ventilation applied in anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days after surgery
Secondary outcomes (10)
Intraoperative brain relaxation.
using a four-point scale: 1, completely relaxed; 2, satisfactorily relaxed; 3, firm brain; 4, bulging brain;
Measured: 1 day undergonging surgery
The postoperative complications within 30 days
Surgical complications，Systematic complications; Septic shock， Death
Measured: 30 days after surgery
Postoperative hypoxemia
PaO2 less than 60 mmHg, SpO2 less than 90%; PaO2 /FiO2 less than 300.
Measured: 7 days after surgery
Peripheral blood inflammatory response indicators
interleukin 6, tumor necrosis factor TNF-α.
Measured: 1 day after surgery
Postoperative antibiotic usage
antibiotic dose
Measured: 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
Measured: 30 days after surgery
Unanticipated ICU treatment.
Unanticipated ICU treatment.
Measured: 30 days after surgery
ICU stay and length of hospital stay
ICU stay and length of hospital stay
Measured: 30 days after surgery
All cause of mortality at 30 days
mortality
Measured: 30 days after surgery
Cost analysis
Data of total non-operative costs, costs per day.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator-induced Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Principal investigator, Wei Zhang, Capital Medical University
- Investigators
- Ruquan Han, MD, Study chair, Department of Anesthesiology, Beijing Tiantan Hospital， Capital Medical Universityliyong Zhang, MD, Study director, Department of Anesthesiology, Beijing Tiantan Hospital， Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386683
- Sponsor's protocol ID
- kY2014-031-02
- Status last verified
- Aug 2023
- First submitted
- 18 Oct 2014
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 29394907
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Lung-Protective Ventilation in Neurosurgery
- ClinicalTrials.gov ID
- NCT02386683
- Acronym / sponsor ID
- kY2014-031-02
- Conditions
- Ventilator-induced Lung Injury
- Keywords
- Protective mechanical ventilation, ventilator-induced lung injury, neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Oct 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Other: lung-protective ventilationlung-protective ventilation applied in anesthesia |
| Group T | No intervention | –traditional ventilation applied in anesthesia |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung-protective ventilationmechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia | Other | Group L |
Primary outcome
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
10 secondary outcomes
Intraoperative brain relaxation.
Time frame: 1 day undergonging surgery
The postoperative complications within 30 days
Time frame: 30 days after surgery
Postoperative hypoxemia
Time frame: 7 days after surgery
Peripheral blood inflammatory response indicators
Time frame: 1 day after surgery
Postoperative antibiotic usage
Time frame: 30 days after surgery
Postoperative pulmonary complications
Time frame: 30 days after surgery
Unanticipated ICU treatment.
Time frame: 30 days after surgery
ICU stay and length of hospital stay
Time frame: 30 days after surgery
All cause of mortality at 30 days
Time frame: 30 days after surgery
Cost analysis
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Derived from this study: PubMed 29394907Zhang 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.
- Individual participant dataSharing planned: No
Related trials for Ventilator-induced Lung Injury
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Not yet recruitingObservational study
Mechanical Power and Mortality in Mechanically Ventilated Adults
Mechanical Ventilation Complication, Ventilator Induced Lung Injury
Active, not recruiting
Respiratory Knowledge Portal Computer and Phone Application to Improve Quality of Mechanical Ventilation by Reducing the Number of Ventilator Associated Events, Injury Created by the Ventilator and Unsafe Setting of Alarms.
Ventilation, ARDS
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Trial of Total Lung Protective Ventilation in Adult VV-ECMO Patients With Severe ARDS
ARDS (Acute Respiratory Distress Syndrome), VV ECMO
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruquan Han, MD study chair
Department of Anesthesiology, Beijing Tiantan Hospital， Capital Medical University
liyong Zhang, MD study director
Department of Anesthesiology, Beijing Tiantan Hospital， Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung-protective ventilation in people with Ventilator-induced Lung Injury, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02386683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.