Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07191509

Effects of Tracheostomy Decannulation on Respiratory Function

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Tracheostomy Decannulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Hongying Jiang

CONTACT

[email protected]

+8656981555

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in Forced Vital Capacity (FVC) [L]

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

    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.

Secondary outcomes

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

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

    Same measurement procedure as for FVC; endpoint is mean change in liters from Day -1 (capped) to Day +5 (oral).

  2. Change in FEV1/FVC Ratio [%]

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

    Calculated from simultaneously measured FEV1 and FVC (FEV1 ÷ FVC × 100). Endpoint is mean percent change between Day -1 and Day +5.

  3. Change in Tidal Volume (VT) [mL]

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

    Average VT of three consecutive quiet breaths recorded by spirometer under the same two time points; higher values denote better function.

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

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

    VE calculated automatically by the spirometer (VT × breathing frequency). Endpoint is mean change from Day -1 to Day +5.

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

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

    Twelve-second MVV manoeuvre converted to one-minute value; mean change between Day -1 and Day +5.

  6. Change in Breathing Frequency (BF) [breaths/min]

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

    Breaths per minute recorded by spirometer during quiet breathing; mean change from baseline to Day +5 (lower values indicate improvement).

  7. Change in Arterial Carbon Dioxide Partial Pressure (PaCO₂) [mm Hg]

    Time frame: Day -1 and Day +5.

    Same blood-gas procedure; endpoint is mean change in PaCO₂.

  8. Change in Arterial Oxygen Partial Pressure (PaO₂) [mm Hg]

    Time frame: Day -1 and Day +5.

    Arterial blood gas sample taken immediately after pulmonary function test at each time point; endpoint is mean change in PaO₂ (mm Hg).

  9. Change in Blood pH [unitless]

    Time frame: Day -1 and Day +5.

    Arterial blood pH measured together with gases; endpoint is mean change (Day -1 to Day +5).

  10. Change in Base Excess (BE) [mmol/L]

    Time frame: Day -1 and Day +5.

    Base Excess from arterial blood gas analysis; endpoint is mean change between the two time points.

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Deng

CONTACT

[email protected]

+8656981423

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.