Successful decannulation group
OtherPatients 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.
NCT Number: NCT07424196
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.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
Bin Zhang
CONTACT
Hongying Jiang
CONTACT
Bin Zhang
Other
Collect Physiological Data of Patients Before and After Tracheostomy Tube Removal Using Wearable Devices to Quantify Physiological Benefits of Decannulation
Acronym: RVTR1
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.
Published trials that share one or more normalized conditions with this study.
NCT07037784
Physiological Parameters
Toulon, Var, France
View Trial DetailsNCT07722260
Physiological Parameters
Damanhūr, Egypt
View Trial DetailsNCT07669090
Anxiety Disorders, High Risk Pregnancy
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06645457
Anxiety, Anxiety Disorders
Muğla, Turkey (Türkiye)
View Trial Details