MedTrace Logo

Predicting Success of Decannulation Using Wearable-derived Physiology

NCT07198425 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-02-27

No results posted yet for this study

Summary

The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping. Each enrolled patient received physiological monitoring upon admission and the day prior to the initial use of the speaking valve, with continuous monitoring for 24 hours through wearable devices.The monitored physiological parameters were compared between the successful decannulation group and the failed decannulation group, and a predictive decannulation model was established in advance based on clinical parameters.

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 \> 100 liters/min, planned removal of the tracheostomy tube can be considered.

Based on decannulation outcomes, patients were categorized into the successful decannulation group and the failed decannulation group.

Successful decannulation group: 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.

Failed decannulation group: Patients who did not pass the decannulation process, and the multidisciplinary team advised against removal of the tracheostomy tube; or patients who passed the decannulation process and had the tracheostomy tube removed but required reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours due to medical conditions.

Conditions

  • Tracheostomy Decannulation
  • Physiological Parameter

Interventions

OTHER

Successful decannulation group

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.

OTHER

Failed decannulation group

Patients who did not pass the decannulation process, and the multidisciplinary team advised against removal of the tracheostomy tube; or patients who passed the decannulation process and had the tracheostomy tube removed but required reinsertion of the tracheostomy tube or endotracheal intubation within 48 hours due to medical conditions.

Sponsors & Collaborators

  • Beijing Rehabilitation Hospital

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Bin Zhang

    lead OTHER

Principal Investigators

  • Hongying Jiang · Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-11-20
Completion
2026-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07198425 on ClinicalTrials.gov