NCT05041894

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2021

Completed
Last Updated

October 11, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

September 8, 2021

Last Update Submit

October 7, 2021

Conditions

Keywords

The stroke patients with tracheotomyDiaphragm excursionDiaphragm thicknessUltrasonography

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • The intraclass correlation coefficient (ICC)

    Within-24h

Interventions

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

Also known as: diaphragm ultrasonography

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The stroke patients with tracheotomy was came from the Shenzhen Second People's Hospital .

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 13, 2021

Study Start

May 22, 2021

Primary Completion

November 22, 2021

Study Completion

December 22, 2021

Last Updated

October 11, 2021

Record last verified: 2021-09

Locations