Inhomogeneous Ventilation in Adult Post-neurosurgical Patients

February 1, 2019 updated by: Jian-Xin Zhou, Capital Medical University

Inhomogeneous Ventilation in Adult Post-neurosurgical Patients: an Observational Study

Inhomogeneous ventilation was more likely to happen in patients after general anesthesia. Inhomogeneous ventilation may associate with ventilator-induced lung injury. A large number of post-neurosurgical patients was delayed extubation and received mechanical ventilation, so that, inhomogeneous ventilation was more likely to happen in the population. Electrical impedance tomography (EIT) is an noninvasive, radiation-free, high temporal resolution, relatively cheap technique in monitoring ventilation distribution bedside. The investigators aimed to investigate the incidence of inhomogeneous ventilation and factors associated with inhomogeneous ventilation in post-neurosurgical patients under mechanical ventilation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Inhomogeneous ventilation was more likely to happen in patients after general anesthesia. Inhomogeneous ventilation may associate with ventilator-induced lung injury since the gravity-depend collapse and over-distention of nondependent regional in patients under mechanical ventilation. A large number of post-neurosurgical patients was delayed extubation and received mechanical ventilation, so that, inhomogeneous ventilation was more likely to happen in the population. Up to now, there is no research reported about the prevalence of inhomogeneous ventilation and the factors associated with inhomogeneous ventilation in post-neurosurgical patients, in present study, The investigators prospectively enrolled adult patients after neurosurgical operations. Electrical impedance tomography (EIT) is an noninvasive, radiation-free, high temporal resolution, relatively cheap technique in monitoring ventilation distribution bedside. The investigators aimed to investigate the incidence of inhomogeneous ventilation and factors associated with inhomogeneous ventilation in post-neurosurgical patients under mechanical ventilation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • ICU, Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult post-neurosurgical patients under mechanical ventilation(MV).

Description

Inclusion Criteria:

  • Undergoing elective neurosurgery operation
  • Trachea intubated and mechanical ventilated

Exclusion Criteria:

  • Age under 18 years-old
  • Unstable hemodynamics patients (mean arterial pressure under 65mmHg) after pharmacotherapy
  • History of chronic obstructive pulmonary disease(COPD) or asthma
  • Contraindication of using EIT (pacemaker, defibrillator, and implantable pumps)
  • Unable to install EIT belt (skin infection, wound)
  • Incompleteness of thorax (e.g. pneumothorax, rib fracture and etc.) or malformation of thorax.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of inhomogeneous ventilation
Time Frame: within 24 hours after neurosurgical operative
In supine position, global image of EIT was divided into upper and lower part, each part accounting for 50%, which was named as non-dependent region and dependent region respectively. Inhomogeneous ventilation was defined as the ratio between tidal impedance variation of dependent region(VTdep) and global tidal impedance variation (VT) is less than 45% during stable Spontaneous breath, which was defined as variation of tidal volume less than 10% in continuous 6 breathes.
within 24 hours after neurosurgical operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of postoperative pulmonary complications(PPCs)
Time Frame: 28 days after neurosurgical operative
Postoperative pulmonary complication was defined as follows: Pneumonia was defined as recent pulmonary infiltration on chest radiography associated with at least 2 of the following signs: purulent tracheobronchial secretion, a body temperature > 38.3℃，and leukocytes in peripheral blood > 25% above the basal count. Tracheobronchitis was an increase in the volume or a change in the color or purulent aspect of tracheobronchial secretion with a normal chest radiograph. Atelectasis was evidence on chest radiography of pulmonary atelectasis associated with acute respiratory symptoms. Bronchoconstriction was classified as the presence of wheezing associated with acute respiratory symptoms with a good response to inhalatory bronchodilator medication.
28 days after neurosurgical operative
Length of ICU stay
Time Frame: through study completion, an average of 7 days
The number of days that patients stay in ICU.
through study completion, an average of 7 days
Length of hospital stay
Time Frame: through study completion, an average of 28 days
The number of days that patients stay in hospital.
through study completion, an average of 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jian-Xin Zhou, MD, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY 2018-006-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings