StrokeNCT05041894
Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke Patients With Tracheotomy by Ultrasonography
An observational study of Stroke and Diaphragm Injury, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Diaphragm Injury, Tracheostomy
- What is being tested?
- tilt table
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2021to 22 Dec 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The stroke patients with tracheotomy was came from the Shenzhen Second People's Hospital .
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Diaphragm Injury, Tracheostomy
- Being tested
- tilt table
- Keywords
- The stroke patients with tracheotomy, Diaphragm excursion, Diaphragm thickness, Ultrasonography
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tilt tableOther
Also called diaphragm ultrasonography
The tilt table provides passive standing for the stroke patients with tracheotomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm excursion
The measurement of the diaphragm dome excursion following the M-mode approach during quiet breathing could provide indirect information about inspiratory volume.
Measured: Half an hour
Diaphragm thickness
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.
Measured: Half an hour
Secondary outcomes (1)
The intraclass correlation coefficient (ICC)
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).
Measured: Within-24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start22 May 2021
- Primary completion22 Nov 2021 (estimated)
- Study completion22 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041894
- Sponsor's protocol ID
- 20210309002-FS01
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke With Tracheotomy : Assessment by Ultrasonography
- ClinicalTrials.gov ID
- NCT05041894
- Acronym / sponsor ID
- 20210309002-FS01
- Conditions
- Stroke, Diaphragm Injury, Tracheostomy
- Keywords
- The stroke patients with tracheotomy, Diaphragm excursion, Diaphragm thickness, Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 22 May 2021 (actual)
- Primary completion
- 22 Nov 2021 (estimated)
- Study completion
- 22 Dec 2021 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The stroke patients with tracheotomy was came from the Shenzhen Second People's Hospital .
Key inclusion criteria (7 listed)
- 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；
Key exclusion criteria (7 listed)
- undergoing mechanical ventilation;
- postural hypotension;
- myocardial infarction in the first 3 months;
- deep vein thrombosis;
- angina or acute heart failure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tilt tableAlso: diaphragm ultrasonographyThe tilt table provides passive standing for the stroke patients with tracheotomy | Other | – |
Primary outcome
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.
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.
1 secondary outcome
The intraclass correlation coefficient (ICC)
Time frame: Within-24h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Diaphragm Injury, run by Shenzhen Second People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm excursion (time frame: Half an hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.