Physiological Benefits From the Removal of Tracheostomy Tubes (Obtained Via Wearable Devices)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorBin Zhang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients underwent clinical and rehabilitation treatment both before and after decannulation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Successful decannulation group
Other interventionPatients 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Physiological Benefits From the Removal of Tracheostomy Tubes (Obtained Via Wearable Devices)
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.
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bin Zhang
Lead sponsor
Capital Medical University
Sponsor institution
Chinese PLA General Hospital
Collaborator
Beijing Rehabilitation Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: