- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01891942
Influence of Trigger Threshold on Controlled Twitch Mouth Pressure
July 2, 2013 updated by: DM Hua, Guangzhou Institute of Respiratory Disease
The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw Pmo) for avoiding glottic closure.
However, the difference in inspiratory pressure trigger threshold may influence the values of Tw Pmo.
We sought to determine the trigger threshold for healthy subjects and COPD patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510120
- Guangzhou Institute Respiratory Disease
-
-
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
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Clinical diagnosis of COPD
- Stable with no episodes of exacerbation within the previous 2 months
- Do not currently being treated with oral corticosteroids
Exclusion Criteria:
- Not stable within the previous 2 months.
- Patients with COPD were currently being treated with oral corticosteroids
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: Diagnostic
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: COPD patients
All of the COPD patients included in this study were stable with no episodes of exacerbation within the previous 2 months.
Patients with COPD were not currently being treated with oral corticosteroids.
|
|
Experimental: normal subjects
Fifteen healthy men with normal lung function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Twitch mouth pressure
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Twitch oesophageal pressure
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Rong-chang Chen, Master, Guangzhou Instiute of Respiratory Disease
- Principal Investigator: Dong-ming Hua, Master, Guangzhou Institue of Respiratory Disease
- Study Chair: Nan-shan Zhong, Bachelor, Guangzhou Institue of Respiratory Disease
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.
General Publications
- Walker DJ, Ertl T, Walterspacher S, Schlager D, Roecker K, Windisch W, Kabitz HJ. Respiratory muscle function during a six-week period of normocapnic hyperpnoea training. Respir Physiol Neurobiol. 2013 Aug 15;188(2):208-13. doi: 10.1016/j.resp.2013.05.005. Epub 2013 May 17.
- Hua DM, Liang YH, Xie YK, Liu Q, Zheng ZG, Chen RC, Zhong NS. Use of twitch mouth pressure to assess diaphragm strength in patients with chronic obstructive pulmonary disease. Respir Physiol Neurobiol. 2013 Jul 1;187(3):211-6. doi: 10.1016/j.resp.2013.04.012. Epub 2013 Apr 15.
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
June 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
June 26, 2013
First Submitted That Met QC Criteria
July 2, 2013
First Posted (Estimate)
July 3, 2013
Study Record Updates
Last Update Posted (Estimate)
July 3, 2013
Last Update Submitted That Met QC Criteria
July 2, 2013
Last Verified
June 1, 2013
More Information
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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