Effects of Tracheostomy Decannulation on Respiratory Function

NCT ID: NCT07191509

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-12-31

Brief Summary

This single-center prospective study enrolls adult patients with long-term tracheostomy who are ready for tube removal (decannulation). Twenty-four hours before decannulation, each participant will receive three physiologic tests-breathing through the tracheostomy tube, breathing with a one-way speaking valve, and breathing with the tube capped. Standard pulmonary-function and arterial-blood-gas measurements will be taken during each test and again 5 days after the tube is removed. The study compares these methods to identify which pre-decannulation test best predicts safe, successful decannulation and to describe the overall impact of tube removal on respiratory function.

Conditions

Tracheostomy Decannulation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube Ventilation

Speaking Valve:

Participants are assessed while breathing through a one-way speaking valve attached to the tracheostomy tube. The valve directs exhaled air through the upper airway, restoring phonation and more closely simulating post-decannulation airflow. The assessment is performed for up to 4 hours to evaluate tolerance and respiratory function prior to tracheostomy tube removal.

Tracheostomy Tube Occlusion:

Participants undergo a capping trial, in which the tracheostomy tube is completely occluded. During this intervention, patients must breathe entirely through their natural upper airway, which increases airway resistance and tests their ability to tolerate decannulation. The capping trial is conducted for 24-48 hours, with monitoring for signs of intolerance.

Tracheostomy Tube Ventilation:

This intervention involves assessment of respiratory function while the participant breathes directly through the open tracheostomy tube, representing the baseline state prior to any decannu

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Tracheostomised patient whose primary illness is stable and who is scheduled for elective decannulation in the rehabilitation unit.
• Able to tolerate a one-way speaking valve for ≥ 4 h on the day before planned decannulation.
• Capable of following instructions and completing bedside spirometry.
• Patient (or legally authorised representative) has provided written informed consent.

Exclusion Criteria

• No tracheostomy in place or requirement for re-intubation/re-cannulation after planned decannulation.
• Inability to perform lung-function testing either via the tracheostomy tube or via the mouth/nose (e.g., severe upper-airway obstruction, facial deformity).
• Unstable cardiopulmonary or neurological status that makes spirometry unsafe (e.g., ongoing myocardial ischemia, uncontrolled arrhythmia, severe agitation).
• Any acute condition requiring isolation precautions that preclude study procedures.
• Refusal or inability to sign informed consent.
• Missing or incomplete key outcome data.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jingyi Ge

Sponsor-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongying Jiang

Role: STUDY_CHAIR

Beijing Rehabilitation Hospital of Capital Medical University

Locations

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, , China

Countries

China

Central Contacts

Jia Deng

Role: CONTACT

djlm1028@126.com

+8656981423

Facility Contacts

Hongying Jiang

Role: primary

6jhy@163.com

+8656981555

Other Identifiers

2025-HXKFZX-FGN-01

Identifier Type: -

Identifier Source: org_study_id