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A prospective, multicenter, randomized, open label, parallel controlled clinical trial evaluating the effectiveness and safety of disposable tracheostomy rehabilitation occluder for postoperative rehabilitation training after tracheotomy

A prospective, multicenter, randomized, open label, parallel controlled clinical trial evaluating the effectiveness and safety of disposable tracheostomy rehabilitation occluder for postoperative rehabilitation training after tracheotomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128041
Enrollment
Unknown
Registered
2026-07-13
Start date
2024-12-13
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Patients with tracheotomy

Interventions

Experimental group:On the basis of rehabilitation training, the disposable air incision occluder was used to exercise and seal the tube
Control group:On the basis of rehabilitation training, the tube was sealed by routine clinical methods

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years old, gender not restricted; 2. Patients with tracheotomy; 3. Have been without the assistance of ventilation equipment for 24 hours, but the tracheotomy tube is still retained; 4. Conscious and able to cooperate with rehabilitation training; 5. The primary disease is in a stable state; 6. The patient has the intention to be extubated; 7. Voluntarily participate in the trial and sign the "Informed Consent Form".

Exclusion criteria

Exclusion criteria: 1. Unconscious or comatose patients; 2. Patients with unstable vital signs, especially poor lung function, decreased lung compliance and elasticity; 3. With clear clinical manifestations of upper airway obstruction or stenosis, or indicated by laryngoscopy/bronchoscopy/CT etc. that the upper airway is narrowed; 4. Patients with a large amount of viscous secretions and difficult to cough them out; 5. After total laryngectomy or laryngotracheal disconnection surgery; 6. Granulation tissue growth at the tracheotomy site, and there is insufficient space around the tracheal tube to allow gas to pass through; 7. The airbag cannot deflate or after deflation, it cannot maintain sufficient ventilation volume; 8. Participants currently participating in other clinical trials; 9. Researchers consider it inappropriate for them to participate in this study.

Design outcomes

Primary

MeasureTime frame
extubation time;

Secondary

MeasureTime frame
respiratory function;swallowing function;speech function;oxyhemoglobin saturation;Success rate of extubation;properties of products;

Countries

China

Contacts

Public ContactHaiyan Li

The First Affiliated Hospital of Wenzhou Medical University

245019500@qq.com+86 577 5557 8027

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026