- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820090
The Predictive Effect of the Inflammatory Response on the Evacuation of Mechanical Ventilation and the Mechanism
June 29, 2016 updated by: Yingmin Ma, Beijing Chao Yang Hospital
Infection and trauma take a important role in the acute respiratory failure.There are different causes and degrees of inflammatory reaction in the critically ill patient.
The inflammatory reaction should also affect patients on mechanical ventilation dependence with body physiological response and disease prognosis in patients.
Therefore, the investigators hypothesize that inflammation may have an important role in the prediction of weaning from mechanical ventilation.
Study Overview
Status
Unknown
Detailed Description
In the process of mechanical ventilation, the patients were divided into two groups according to the failure of spontaneous breathing test and spontaneous breathing test.In the index of predicting mechanical ventilation, the investigators will take the index of inflammatory response, the function index of diaphragm and the amount of exhaled CO2 into account to reduce the failure rate of mechanical ventilation.
Study Type
Observational
Enrollment (Anticipated)
300
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
14 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patient with oral or nasal tracheal intubation and mechanical ventilation in respiratory failure
Description
Inclusion Criteria:
- oral, nasal tracheal intubation and mechanical ventilation in patients with respiratory failure
- mechanical ventilation time over than 48 hours
- Glasgow score greater more than or equal to 13 points
Exclusion Criteria:
- Aged less than 14 years or more than 80 years old
- patients with neuromuscular disease
- pure heart failure pulmonary edema patients
- patients with tracheotomy
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 |
|---|
|
Success with SBT
The patient have a success in SBT.
|
|
Success with mechanical ventilation
Weaning from mechanical ventilation is successful
|
|
failure with SBT
The patient have a failure in SBT.
|
|
failure with mechanical ventilation
Weaning from mechanical ventilation is failed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The relationship between mechanical ventilation of ventilator and inflammatory response
Time Frame: January 2014 to December 2016
|
Through the study of mechanical ventilation weaning success and failure of patients with respiratory physiological indicators, blood, urine related inflammatory indicators, analysis of the relationship between inflammatory response and mechanical ventilation weaning.The test indicators include C- reactive protein, tumor necrosis factor and some interleukin for related.
|
January 2014 to December 2016
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The relationship between diaphragm movement function and weaning from mechanical ventilation
Time Frame: January 2016 to December 2017
|
To study the relationship between the inflammatory response and the contractile function of diaphragm, which is helpful to judge the effect of inflammatory factors on the evacuation of mechanical ventilation.
|
January 2016 to December 2017
|
|
the output of CO2
Time Frame: January 2016 to December 2017
|
January 2016 to December 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: MA yingmin, professor, Beijing Chao Yang 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
May 1, 2014
Primary Completion (Anticipated)
April 1, 2017
Study Completion (Anticipated)
April 1, 2017
Study Registration Dates
First Submitted
May 31, 2016
First Submitted That Met QC Criteria
June 29, 2016
First Posted (Estimate)
June 30, 2016
Study Record Updates
Last Update Posted (Estimate)
June 30, 2016
Last Update Submitted That Met QC Criteria
June 29, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15210511726
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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