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Inhomogeneous Ventilation in Adult Post-neurosurgical Patients

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ClinicalTrials.gov Identifier: NCT03830099
Recruitment Status : Unknown
Verified February 2019 by Jian-Xin Zhou, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University

Study Description
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Brief Summary:
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.

Condition or disease
Mechanical Ventilation Electrical Impedance Tomography Inhomogeneous Ventilation Neurosurgery

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Other
Official Title: Inhomogeneous Ventilation in Adult Post-neurosurgical Patients: an Observational Study
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : August 31, 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Length of ICU stay [ Time Frame: through study completion, an average of 7 days ]
    The number of days that patients stay in ICU.

  3. Length of hospital stay [ Time Frame: through study completion, an average of 28 days ]
    The number of days that patients stay in hospital.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gender was based on basic information collected at the moment when patients was admitted to hospital.
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult post-neurosurgical patients under mechanical ventilation(MV).
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830099


Contacts
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Contact: Jian-Xin Zhou, MD 8610 67096579 zhoujx.cn@icloud.com

Locations
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China, Beijing
ICU, Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Jian-Xin Zhou, MD       zhoujx.cn@icloud.com   
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Jian-Xin Zhou, MD Beijing Tiantan Hospital
More Information
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Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT03830099    
Other Study ID Numbers: KY 2018-006-01
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No