Effects of Tracheostomy Decannulation on Respiratory Function

March 9, 2026 updated by: Jingyi Ge, Capital Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day -1) and Day +5 after decannulation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline (Day -1) and Day +5 after decannulation.
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.
Baseline (Day -1) and Day +5 after decannulation.
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.
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.
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]
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.
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.
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]
Time Frame: Day -1 and Day +5.
Same blood-gas procedure; endpoint is mean change in PaCO₂.
Day -1 and Day +5.
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).
Day -1 and Day +5.
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).
Day -1 and Day +5.
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.
Day -1 and Day +5.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hongying Jiang, Beijing Rehabilitation Hospital of Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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