NCT02386683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

4.4 years

First QC Date

October 18, 2014

Last Update Submit

August 28, 2023

Conditions

Ventilator-induced Lung Injury

Keywords

Protective mechanical ventilationventilator-induced lung injuryneurosurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Intraoperative brain relaxation.

    1 day undergonging surgery

  • The postoperative complications within 30 days

    30 days after surgery

  • Postoperative hypoxemia

    7 days after surgery

  • Peripheral blood inflammatory response indicators

    1 day after surgery

  • Postoperative antibiotic usage

    30 days after surgery

  • +5 more secondary outcomes

Study Arms (2)

Group L

ACTIVE COMPARATOR

lung-protective ventilation applied in anesthesia

Other: lung-protective ventilation

Group T

NO INTERVENTION

traditional ventilation applied in anesthesia

Interventions

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

Group L

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

  • 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.

    PMID: 29394907DERIVED

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ruquan Han, MD

    Department of Anesthesiology, Beijing Tiantan Hospital， Capital Medical University

    STUDY CHAIR

  • liyong Zhang, MD

    Department of Anesthesiology, Beijing Tiantan Hospital， Capital Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

October 18, 2014

First Posted

March 12, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2020

Study Completion

November 1, 2020

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)