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The aim of this study is to evaluate the feasibility of predicting upper airway patency in patients with prolonged tracheostomy using a non-invasive method combining speaking valve (SV) and transtracheal end-expiratory pressure (TTPEE) through a multicenter study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True positive group | Experimental | Upper airway non-patency is defined as positive; otherwise, it is negative. The true positive group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are positive. |
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| False positive group | Experimental | Upper airway non-patency is defined as positive; otherwise, it is negative. The false positive group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is positive, and the result of the bronchoscopy is negative. |
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| True negative group | Experimental | Upper airway non-patency is defined as positive; otherwise, it is negative. The true negative group is defined as those for whom both the results of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol and the bronchoscopy are negative. |
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| False negative group | Experimental | Upper airway non-patency is defined as positive; otherwise, it is negative. The false negative group is defined as the group in which the result of the speaking valve (SV) with the transtracheal end-expiratory pressure (TTPEE) measurement protocol is negative, and the result of the bronchoscopy is positive. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Speaking valve combined with airway pressure | Diagnostic Test | All patients wore speaking valves for 30 minutes, during which the transtracheal end-expiratory pressure was measured to assess the patency of the upper airway. |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement in predicting upper airway patency | Patients enrolled in the study will undergo both SV with transtracheal end-expiratory pressure measurement and bronchoscopy. Upper airway non-patency will be defined as positive. Using the results of bronchoscopy as the gold standard, the sensitivity and specificity of SV with transtracheal end-expiratory pressure measurement will be evaluated. | The patients started using the SV with the TTPEE measurement on the day of enrollment. After that, bronchoscopy should be performed within 48 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongying Jiang, MD | Contact | +8656981555 | 6jhy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongying Jiang, MD | Beijing Rehabilitation Hospital of Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Rehabilitation Hospital | Recruiting | Hunan | Hunan | 410000 | China |
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| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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All patients received the speaking valve combined with the transtracheal end-expiratory pressure measurement protocol and bronchoscopy.
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| Bronchoscopy | Diagnostic Test | The same examiner performed bronchoscopy on all patients to assess upper airway patency. |
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| Jiangbin Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Guangxi | Jiangbin | 530012 | China |
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| Beijing Rehabilitation Hospital of Capital Medical University | Recruiting | Beijing | Shijingshan | 100144 | China |
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| YanBian University Hospital | Recruiting | Jilin City | Yanbian | 133000 | China |
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| Zhengzhou Central Hospital Affiliated to Zhengzhou University | Recruiting | Henan | Zhengzhou | 450007 | China |
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| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |