Mechanical VentilationNCT03830099
Inhomogeneous Ventilation in Adult Post-neurosurgical Patients
An observational study of Mechanical Ventilation and Electrical Impedance Tomography, run by Capital Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Electrical Impedance Tomography, Inhomogeneous Ventilation
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 31 Aug 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult post-neurosurgical patients under mechanical ventilation(MV).
Who may be able to join
- Undergoing elective neurosurgery operation
- Trachea intubated and mechanical ventilated
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Jian-Xin Zhou, MD, zhoujx.cn@icloud.com
About this study
Official title: 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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of inhomogeneous ventilation
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.
Measured: within 24 hours after neurosurgical operative
Secondary outcomes (3)
The incidence of postoperative pulmonary complications(PPCs)
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.
Measured: 28 days after neurosurgical operative
Length of ICU stay
The number of days that patients stay in ICU.
Measured: through study completion, an average of 7 days
Length of hospital stay
The number of days that patients stay in hospital.
Measured: through study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Apr 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830099
- Sponsor's protocol ID
- KY 2018-006-01
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhomogeneous Ventilation in Adult Post-neurosurgical Patients: an Observational Study
- ClinicalTrials.gov ID
- NCT03830099
- Acronym / sponsor ID
- KY 2018-006-01
- Conditions
- Mechanical Ventilation, Electrical Impedance Tomography, Inhomogeneous Ventilation, Neurosurgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 5 Feb 2019 (actual)
- 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.
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.
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
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult post-neurosurgical patients under mechanical ventilation(MV).
Key inclusion criteria (2 listed)
- Undergoing elective neurosurgery operation
- Trachea intubated and mechanical ventilated
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
The incidence of postoperative pulmonary complications(PPCs)
Time frame: 28 days after neurosurgical operative
Length of ICU stay
Time frame: through study completion, an average of 7 days
Length of hospital stay
Time frame: through study completion, an average of 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
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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.
Jian-Xin Zhou, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Electrical Impedance Tomography, 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, MD (8610 67096579, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of inhomogeneous ventilation (time frame: within 24 hours after neurosurgical operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2019.