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

• Conditions: Diaphragm Injury; Stroke; Tracheostomy

• Registration Number: NCT05041894
• Lead Sponsor: Shenzhen Second People's Hospital

Brief 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.

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 Timeline

• Study Start: 2021-05-22
• Status Verified: 2021-09
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-13
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-11
• Primary Completion: 2021-11-22
• Study Completion: 2021-12-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragm excursion	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	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.

Secondary Outcome Measures

Name	Time	Method
The intraclass correlation coefficient (ICC)	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).

Trial Locations

Locations (1)

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, China