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NCT Number: NCT07424196

Physiological Benefits From the Removal of Tracheostomy Tubes (Obtained Via Wearable Devices)

The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. After the patient is admitted, the research team evaluates whether they are suitable to enter the decannulation process. For enrolled patients, a 24-hour wearable device is worn upon admission to record physiological parameters.

Patients, following clinical and rehabilitation treatment, can start using a "speaking valve" as soon as their condition permits. Within the first 24 hours prior to the initial use of the speaking valve, wearable devices may be utilized a second time to gather data.

Patients successfully completed the decannulation process, tolerating the speaking valve for 4 hours (PEF/PCF ≥ 100liters/min).The wearable device was utilized to gather 24 hours physiological parameters for the third time within the 24 hours leading up to decannulation.

Patients who underwent successful decannulation had physiological parameters collected for the forth time using wearable devices within 24 hours prior to discharge.

This study preliminarily compares the differences in physiological parameters at four time points (within 24 hours of admission, within 24 hours prior to using a speaking valve, within 24 hours prior to decannulation and within 24 hours before discharge), predicts the physiological benefits of decannulation for patients, and advocates for the concept of "early decannulation." Decannulation criteria: If the patient can tolerate wearing the speaking valve continuously for 4 hours (gradually increasing the duration: 30 minutes, 1 hour, 2 hours, 4 hours), and if PEF/PCF ≥ 100 liters/min, planned removal of the tracheostomy tube can be considered.

Criteria for successful decannulation: Patients who successfully completed the decannulation process and had their tubes removed, with no reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours after decannulation.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years≤Age≤90 years, non-mechanically ventilated patients.
  • Tracheotomy completed, ≥48 hours since cannula placement (postoperative early edema has stabilized).
  • Patient or legal representative has provided informed consent.
  • Following our department's 2018 decannulation procedure, patients who successfully completed decannulation

Exclusion criteria

  • Patients with abnormal skin conditions preventing continuous wearing of monitoring devices;
  • Interruption of physiological monitoring data;
  • Poor quality of physiological monitoring data;
  • Recent (≤48 hours) major neck/upper airway surgery requiring avoidance of upper airway airflow impact.
  • Severe consciousness disorder/delirium (RASS ≤ -3 or ≥ +2), extreme anxiety/inability to cooperate.
  • Total laryngectomy or laryngo-tracheal separation.
  • Age <18 years, Age > 90years.
  • Malignant tumor with an expected survival time ≤ 6 months.
  • Patients or legal representatives unable to obtain informed consent.
  • Known contraindications for tracheotomy decannulation.
  • Unable to comply with the use of wearable devices

Treatment and study plan

Successful decannulation group

Other

Patients who successfully completed the decannulation process and had their tubes removed, with no reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours after decannulbation.

Primary outcomes

  1. Physiological Benefits From the Removal of Tracheostomy Tubes (Obtained Via Wearable Devices)

    Time frame: within 24 hours of admission, within 24 hours prior to using a speaking valve, within 24 hours prior to decannulation and within 24 hours before discharge.

    All patients enrolled in this study had their tracheostomy cannula successfully removed during hospitalization, and no tracheostomy cannula or orotracheal intubation was reinserted within 48 hours following decannulation.Primary Objectives: The clinical benefits of decannulation were further validated by observing the changes in patients' physiological parameters before and after the procedure.In clinical practice, we actively advocate for decannulation management through "early assessment, prompt decannulation, early advantage" to minimize unnecessary indwelling.

Study contacts

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

Bin Zhang

CONTACT

[email protected]

+8618600530758

Hongying Jiang

CONTACT

[email protected]

+8601056981555

Sponsors and collaborators

Lead sponsor

Bin Zhang

Other

Collaborators

  • Beijing Rehabilitation Hospital
  • Chinese PLA General Hospital

Registry information

Official study title

Collect Physiological Data of Patients Before and After Tracheostomy Tube Removal Using Wearable Devices to Quantify Physiological Benefits of Decannulation

Acronym: RVTR1

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2026
Registry last updated
Jun 3, 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.

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