the effect of external subglottic air flow on pharyngeal secretions in tracheotomized patients with neurogenic disease: a randomized controlled study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400084911

Enrollment

Unknown

Registered

2024-05-28

Start date

2024-06-01

Completion date

Unknown

Last updated

2024-06-03

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

Conditions

tracheotomized patients with neurogenic disease

Interventions

treatment group:external subglottic air flow

wait-list control group:external subglottic air flow was given at the end of the waiting period

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The primary disease of all subjects was central nervous system disease; 2. All subjects were stable, and after 1 week of tracheotomy, patients with indwelling plastic tracheal tubes, with air sacs and subportal drainage tubes; 3. Patients who can not tolerate tracheal tube balloon deflating; 4. Duration of disease within 1 year; 5. Age =18 years old; 6. Patients or family members are aware of this study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious complications such as heart failure, liver failure, kidney failure, etc.; 2. Patients with ventilator-assisted mechanical ventilation; 3. Patients with cancer and HIV infection; 4. Upper airway obstruction: including upper airway obstruction or stenosis exceeding half of the airway cross-sectional area, tracheal collapse, and severe vocal cord paralysis affecting airflow through patients; 5. Patients who have been treated with botox injection into salivary glands; 6. Patients with contraindicated swallowing laryngoscopy (FEES) (such as skull base/facial fracture facial trauma; Recent intractable epistaxis; Bilateral nasal obstruction due to tamponade or posterior nostril atresia; Patients with severe agitation; Patients who are unable to cooperate with the examination; Patients with acute vasovagal attack risk and bradycardia, etc.); 7. Patients with unhealed wound at tracheostomy, tracheostomy site infection or bleeding.

Design outcomes

Primary

Measure	Time frame
Marianjoy secretion severity scale score;	—

Secondary

Measure	Time frame
Total daily secretions;Spontaneous swallowing frequency within 20 minutes;Pharyngeal sensation test;	—

Countries

China

Contacts

Public ContactXiquan Hu

The Third Affiliated Hospital of Sun Yat-Sen University

huxiquan@mail.sysu.edu.cn+86 189 2210 2910

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026