Menu
Recruiting NCT07191509

Effects of Tracheostomy Decannulation on Respiratory Function

— Observational Tracheostomy Decannulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube Ventilation.
Who it may be relevant to
Registry conditions: Tracheostomy Decannulation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study on the Impact of Tracheostomy Decannulation on Pulmonary Function in Adult Patients

Overview

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.

Interventions

  • Device 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 completel

Primary outcome measures

  • Change in Forced Vital Capacity (FVC) [L] [Time frame: Baseline (Day -1) and Day +5 after decannulation.]
Secondary outcome measures (10)
  • Change in Forced Expiratory Volume in 1 Second (FEV1) [L] [Time frame: Baseline (Day -1) and Day +5 after decannulation.]
  • Change in FEV1/FVC Ratio [%] [Time frame: Baseline (Day -1) and Day +5 after decannulation.]
  • Change in Tidal Volume (VT) [mL] [Time frame: Baseline (Day -1) and Day +5 after decannulation.]
  • Change in Minute Ventilation (VE) [L/min] [Time frame: Baseline (Day -1) and Day +5 after decannulation.]
  • Change in Maximum Voluntary Ventilation (MVV) [L/min] [Time frame: Baseline (Day -1) and Day +5 after decannulation.]
  • Change in Breathing Frequency (BF) [breaths/min] [Time frame: Baseline (Day -1) and Day +5 after decannulation.]
  • Change in Arterial Carbon Dioxide Partial Pressure (PaCO₂) [mm Hg] [Time frame: Day -1 and Day +5.]
  • Change in Arterial Oxygen Partial Pressure (PaO₂) [mm Hg] [Time frame: Day -1 and Day +5.]
  • Change in Blood pH [unitless] [Time frame: Day -1 and Day +5.]
  • Change in Base Excess (BE) [mmol/L] [Time frame: Day -1 and Day +5.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Rehabilitation Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07191509 · 2025-HXKFZX-FGN-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗