Effects of Tracheostomy Decannulation on Respiratory Function

NCT07191509 | Recruiting DMC

• 1 other identifier: 2025-HXKFZX-FGN-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Speaking Valve; Pulmonary Function Test; Tracheostomy Tube Occlusion; Tracheostomy Decannulation

Outcome Measures

Primary Outcomes (1)

• Change in Forced Vital Capacity (FVC) [L]

  FVC is obtained with a calibrated portable spirometer. Three acceptable manoeuvres are performed and the highest value kept. Baseline is recorded on Day -1 while the tracheostomy tube is capped; the same test is repeated on Day +5 during oral breathing after successful decannulation. The endpoint is the mean change (Day +5 minus Day -1) in liters; higher values indicate better respiratory function.

  Baseline (Day -1) and Day +5 after decannulation.

Secondary Outcomes (10)

• Change in Forced Expiratory Volume in 1 Second (FEV1) [L]

  Baseline (Day -1) and Day +5 after decannulation.

• Change in FEV1/FVC Ratio [%]

  Baseline (Day -1) and Day +5 after decannulation.

• Change in Tidal Volume (VT) [mL]

  Baseline (Day -1) and Day +5 after decannulation.

• Change in Minute Ventilation (VE) [L/min]

  Baseline (Day -1) and Day +5 after decannulation.

• Change in Maximum Voluntary Ventilation (MVV) [L/min]

  Baseline (Day -1) and Day +5 after decannulation.

Interventions

Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube Ventilation DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (≥18 years) in-patients with a pre-existing tracheostomy who are receiving multidisciplinary rehabilitation care at the Respiratory Rehabilitation Center of Beijing Rehabilitation Hospital, Capital Medical University. All candidates have a stable primary illness, are clinically judged ready for elective decannulation, can tolerate a one-way speaking valve for at least 4 hours, and are able to cooperate with bedside spirometry tests. Both sexes and all underlying diagnoses that required tracheostomy (e.g., neurologic, traumatic, postsurgical or pulmonary conditions) are eligible provided they meet the inclusion/exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, China

RECRUITING

Study Officials

• Hongying Jiang

  Beijing Rehabilitation Hospital of Capital Medical University

  STUDY CHAIR

Central Study Contacts

Jia Deng

CONTACT

+8656981423; djlm1028@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)