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Restoring pressures in upper airway and mechanism of biological fluid mechanics in acquired brain damage patients with the aspiration after tracheotomy

Restoring pressures in upper airway and mechanism of biological fluid mechanics in acquired brain damage patients with the aspiration after tracheotomy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018686
Enrollment
Unknown
Registered
2018-10-03
Start date
2015-01-01
Completion date
Unknown
Last updated
2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired brain damage

Interventions

Patients after tracheotomy group 1:Passy-Muir swallowing and speaking valve
Patients after tracheotomy group 2:Conventional treatments

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Tracheotomized patients after acquired brain damage; 2. CT/MRI confirmed; 3. Aged 25-70 years; 4. Course 1-12 months; 5. Aspiration exists after dye test; 6. Patients who cannot tolerate tube sealing or removing the tracheal tube; 7. with no history of dysphagia before; 8. Voluntary participation and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Conscious disturbance or using artificial ventilator to assist ventilation; 2. Obvious cognitive dysfunction; 3. Severe lung infection; 4. Can not tolerate balloon deflated; 5. With medical history of vocal cord paralysis, upper airway stenosis, upper respiratory system disease, tracheoesophageal fistula, seizures and risks of seizures; 6. Completely closed UES; 7. Allergic to iohexol injection; 8. Any neuropsychiatric comorbidity and affective disorder that could influence the test outcomes; 9. Any other factors that could affect cognitive assessments and treatments.

Design outcomes

Primary

MeasureTime frame
Pharyngeal pressure waveform;Kinematic and temporal parameters of swallowing;The upper airway flow characteristics;

Countries

China

Contacts

Public ContactDou Zulin

The Third Affiliated Hospital of Sun Yat-sen University

douzul@163.com+86 18922102718

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026