- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02592122
Airway Responsiveness in Patients With AECOPD Mechanical Ventilation by Inspiratory and Bronchial Dilation Testchronic Obstructive Pulmonary Disease
October 29, 2015 updated by: snow
In the patients with COPD mechanical ventilation, the bronchial dilatation is very common.
However, the evaluation of the efficacy of the medical examination and other subjective indicators, such as doctors, depends on the doctor's experience; at present, there is no objective evaluation index.
For patients with mechanical ventilation, the risk of cross infection can not only increase the risk of cross infection, but also increase the workload of clinical doctors and nurses.
Therefore, this study proposes an objective evaluation method to evaluate the response of COPD patients to bronchial dilation.
The hypothesis of this study can be used to guide the clinical medication through the test of the bronchus.
If the patients with bronchial dilation test positive were used in the test, the patients were not used.
In this evaluation method, the changes of airway resistance were measured by the accurate measurement of the patients with inhaled bronchial dilatation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
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
- Name: Xue Wang, MB
- Phone Number: 0086-10-85231543
- Email: rtxue2013@sina.com
Study Contact Backup
- Name: Sun Bing, MD
- Phone Number: 86013911151075
- Email: ricusunbing@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100020
- Recruiting
- Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
-
Contact:
- Bing Sun, MD
- Phone Number: 86013911151075
- Email: ricusunbing@126.com
-
Contact:
- Xue Wang, MB
- Phone Number: 0086-10-85231543
- Email: rtxue2013@sina.com
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acute exacerbation of chronic obstructive pulmonary disease
- The mechanical ventilation time of the outdoor endotracheal intubation in the intensive care unit was less than 48 hours
Exclusion Criteria:
- asthma
- has received tracheotomy
- long term mechanical ventilation (which has been accepted for more than 21 days).
- severe pneumonia
- Patients who cannot use a patient with bronchial dilation
- there's a taboo on the use of a sedative.
- refusal to participate in the study
- 48 hours to pull out the tube
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Atomization inhalation
First of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Second, randomly selected into the atomization group
|
Other Names:
|
Active Comparator: Without atomization inhalation
First of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Secondly, the random selection is not the atomization group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
airway resistance
Time Frame: 1 day
|
The first test of bronchial dilatation
|
1 day
|
Respiratory mechanics index:PEEPi
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
length of hospital stay
Time Frame: 30 days
|
30 days
|
Costs of hospitalization expenses
Time Frame: 30 days
|
30 days
|
Mechanical ventilation time
Time Frame: 28 days
|
28 days
|
Routine blood test:Eosinophilic cells
Time Frame: 7days
|
7days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bing Sun, Beijing Chao Yang Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2013
Primary Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
October 11, 2015
First Submitted That Met QC Criteria
October 29, 2015
First Posted (Estimate)
October 30, 2015
Study Record Updates
Last Update Posted (Estimate)
October 30, 2015
Last Update Submitted That Met QC Criteria
October 29, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
- Bromides
Other Study ID Numbers
- 2013-10-COPD
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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