Effects of Tracheostomy Decannulation on Respiratory Function

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheostomy Decannulation
• Intervention / Treatment: Device: Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube Ventilation

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jia Deng; Phone Number: +8656981423; Email: djlm1028@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Rehabilitation Hospital, Capital Medical University
    • Contact: Hongying Jiang; Phone Number: +8656981555; Email: 6jhy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Forced Expiratory Volume in 1 Second (FEV1) [L]	Same measurement procedure as for FVC; endpoint is mean change in liters from Day -1 (capped) to Day +5 (oral).	Baseline (Day -1) and Day +5 after decannulation.
Change in FEV1/FVC Ratio [%]	Calculated from simultaneously measured FEV1 and FVC (FEV1 ÷ FVC × 100). Endpoint is mean percent change between Day -1 and Day +5.	Baseline (Day -1) and Day +5 after decannulation.
Change in Tidal Volume (VT) [mL]	Average VT of three consecutive quiet breaths recorded by spirometer under the same two time points; higher values denote better function.	Baseline (Day -1) and Day +5 after decannulation.
Change in Minute Ventilation (VE) [L/min]	VE calculated automatically by the spirometer (VT × breathing frequency). Endpoint is mean change from Day -1 to Day +5.	Baseline (Day -1) and Day +5 after decannulation.
Change in Maximum Voluntary Ventilation (MVV) [L/min]	Twelve-second MVV manoeuvre converted to one-minute value; mean change between Day -1 and Day +5.	Baseline (Day -1) and Day +5 after decannulation.
Change in Breathing Frequency (BF) [breaths/min]	Breaths per minute recorded by spirometer during quiet breathing; mean change from baseline to Day +5 (lower values indicate improvement).	Baseline (Day -1) and Day +5 after decannulation.
Change in Arterial Carbon Dioxide Partial Pressure (PaCO₂) [mm Hg]	Same blood-gas procedure; endpoint is mean change in PaCO₂.	Day -1 and Day +5.
Change in Arterial Oxygen Partial Pressure (PaO₂) [mm Hg]	Arterial blood gas sample taken immediately after pulmonary function test at each time point; endpoint is mean change in PaO₂ (mm Hg).	Day -1 and Day +5.
Change in Blood pH [unitless]	Arterial blood pH measured together with gases; endpoint is mean change (Day -1 to Day +5).	Day -1 and Day +5.
Change in Base Excess (BE) [mmol/L]	Base Excess from arterial blood gas analysis; endpoint is mean change between the two time points.	Day -1 and Day +5.

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Study Chair: Hongying Jiang, Beijing Rehabilitation Hospital of Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 15, 2025
• First Submitted That Met QC Criteria: September 23, 2025
• First Posted (Actual): September 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Pulmonary Function Test; Speaking Valve; Tracheostomy Tube Occlusion; Tracheostomy Decannulation
• Other Study ID Numbers: 2025-HXKFZX-FGN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No