Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke Patients With Tracheotomy by Ultrasonography

Stroke Clinical Trial

Official title:

Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke With Tracheotomy : Assessment by Ultrasonography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05041894
• Other study ID #: 20210309002-FS01
• Status: Active, not recruiting
• Start date: May 22, 2021
• Est. completion date: December 22, 2021

Study information

• Verified date: September 2021
• Source: Shenzhen Second People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: December 22, 2021
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. currently diagnosed with ischemic or hemorrhagic stroke by CT or MRI;

2. right unilateral or bilateral limb with hemiparesis;

3. age over 18 years;

4. BMI<35 kg/m2;

5. within 2 weeks to 12 months;

6. the tracheotomy tube replacement;

7. non first time standing assisted with tilt table.

Exclusion Criteria:

1. undergoing mechanical ventilation;

2. postural hypotension;

3. myocardial infarction in the first 3 months;

4. deep vein thrombosis;

5. angina or acute heart failure;

6. complicated with other primary pulmonary diseases, such as tuberculosis,;pneumothorax, and chronic obstructive pulmonary disease and so on;

7. a past episode of abdominal or chest surgery.

Related Conditions & MeSH terms

• Diaphragm Injury
• Stroke
• Tracheostomy

Intervention

Other:
• tilt table
The tilt table provides passive standing for the stroke patients with tracheotomy

Locations

Country	Name	City	State
China	Shenzhen Second People's Hospital	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm excursion	The measurement of the diaphragm dome excursion following the M-mode approach during quiet breathing could provide indirect information about inspiratory volume.	Half an hour
Primary	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.	Half an hour
Secondary	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).	Within-24h