- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05041894
Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke Patients With Tracheotomy by Ultrasonography
October 7, 2021 updated by: Shenzhen Second People's Hospital
Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke With Tracheotomy : Assessment by Ultrasonography
The purpose of this study was to examine whether if the effect of standing with assistance of the tilt table on diaphragm excursion and thickness in the stroke patients with tracheotomy.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
40-45 stroke patients with tracheotomy were passive tilting (α=0°, 30°, 60°) by an electric tilt table in the random order.
The diaphragm excursion and thickness were measured by ultrasonography on three tilting during the quiet breathing.
Besides, the intraclass correlation coefficient (ICC) were calculated to assess the reliability of the diaphragm ultrasonography in this population.
Study Type
Observational
Enrollment (Anticipated)
41
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
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-
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Shenzhen, China
- Shenzhen Second People's Hospital
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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
Probability Sample
Study Population
The stroke patients with tracheotomy was came from the Shenzhen Second People's Hospital .
Description
Inclusion Criteria:
- currently diagnosed with ischemic or hemorrhagic stroke by CT or MRI;
- right unilateral or bilateral limb with hemiparesis;
- age over 18 years;
- BMI<35 kg/m2;
- within 2 weeks to 12 months;
- the tracheotomy tube replacement;
- non first time standing assisted with tilt table.
Exclusion Criteria:
- undergoing mechanical ventilation;
- postural hypotension;
- myocardial infarction in the first 3 months;
- deep vein thrombosis;
- angina or acute heart failure;
- complicated with other primary pulmonary diseases, such as tuberculosis,;pneumothorax, and chronic obstructive pulmonary disease and so on;
- a past episode of abdominal or chest surgery.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diaphragm excursion
Time Frame: Half an hour
|
The measurement of the diaphragm dome excursion following the M-mode approach during quiet breathing could provide indirect information about inspiratory volume.
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Half an hour
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Diaphragm thickness
Time Frame: Half an hour
|
The diaphragm thickness was measured by B-mode approach providing clear visualization of the diaphragm morphology at the zone of apposition at the quiet breathing on the three tilting.
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Half an hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The intraclass correlation coefficient (ICC)
Time Frame: Within-24h
|
For the ultrasonography assessment, the intraclass correlation coefficient (ICC) was analyzed by using the two-way mixed-effects ICC [2.1] model with 95% confidence intervals (CIs).
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Within-24h
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Collaborators and Investigators
This is where you will find people and organizations involved with this 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 (Actual)
May 22, 2021
Primary Completion (Anticipated)
November 22, 2021
Study Completion (Anticipated)
December 22, 2021
Study Registration Dates
First Submitted
September 8, 2021
First Submitted That Met QC Criteria
September 8, 2021
First Posted (Actual)
September 13, 2021
Study Record Updates
Last Update Posted (Actual)
October 11, 2021
Last Update Submitted That Met QC Criteria
October 7, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20210309002-FS01
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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