- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03241654
Decreasing Trigger Sensitivity Could Assist PEEP to Further Improve Regional Ventilation Distribution
February 9, 2018 updated by: Jian-Xin Zhou, Capital Medical University
Decreasing Trigger Sensitivity Could Assist PEEP to Further Improve Regional Aeration and Homogeneity During Pressure Assist Ventilation: A Preliminarily Physiological Study
In mechanically ventilated patients during supine position, alveolar collapse usually distributes in dependent lung region.Decrease of flow trigger sensitivity might improve homogeneous of tidal volume distribution.
Study Overview
Detailed Description
In mechanically ventilated patients during supine position, alveolar collapse usually distributes in dependent lung region.
High positive end expiratory pressure (PEEP) has been applied to improve the homogeneous distribution of ventilation by increasing the end expiratory lung ventilation (EELV) and alveolar recruitment.
However, for patients who increasing PEEP in some extent still existed poor aeration in the dependent region, further elevating PEEP seems to be unreasonable that perhaps lead to overdistension.
Decreasing trigger sensitivity might further evoke inspiratory efforts to improve the ventilation for this type of patients.The Electrical impedance tomography (EIT) was applied in monitoring the regional ventilation distribution at the bedside.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Jian-Xin Zhou
-
-
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
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The postoperative patients receiving pressure support ventilation and existing heterogenous ventilation.
Description
Inclusion Criteria:
- The post operative patients who received pressure support ventilation;
- After the clinical PEEP was evaluated 5cmH2O, the tidal volume distribution still existed heterogeneity.
Exclusion Criteria:
- Under 18 years;
- History of diaphragm dysfunction and surgery;
- Central respiratory drive dysfunction;
- history of esophageal, gastric or lung surgery;
- The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
the lowest trigger sensitivity
The flow trigger of ventilator was set as the lowest level of sensitivity.
|
The flow trigger will be adjust during the pressure assist ventilation.
|
|
the highest trigger sensitivity
The flow trigger of ventilator was set as the highest level of sensitivity.
|
The flow trigger will be adjust during the pressure assist ventilation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The homogeneity of distribution of tidal volume
Time Frame: within 20 minutes after changing flow trigger
|
EIT was used to monitoring the homogeneity of distribution of tidal volume that was divided into two contiguous regions of interest (ROI) equally, the dependent and non-dependent area.
The ratio of relative distribution of tidal ventilation of two ROI was calculated.
|
within 20 minutes after changing flow trigger
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in global and regional EELV
Time Frame: within 20 minutes after changing flow trigger
|
The change of EELV was measured after changing flow trigger based on the baseline level.
|
within 20 minutes after changing flow trigger
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
May 1, 2017
Primary Completion (Actual)
August 20, 2017
Study Completion (Actual)
February 1, 2018
Study Registration Dates
First Submitted
August 3, 2017
First Submitted That Met QC Criteria
August 4, 2017
First Posted (Actual)
August 7, 2017
Study Record Updates
Last Update Posted (Actual)
February 12, 2018
Last Update Submitted That Met QC Criteria
February 9, 2018
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY-2017-001
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.
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