The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy

Study Overview
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Brief Summary
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to evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy.

Detailed Description
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To evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy. Comparing the difference between two groups in the operating duration, extubation duration, total anesthesia time, heart rate, blood pressure and arterial blood gas analysis. This is a prospective, randomized, controlled trial.

Official Title
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The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy:A Prospective, Randomized, Controlled Trial

Conditions
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Transbronchial Cryobiopsy, Anesthesia, Tracheal Intubation, Rigid Bronchoscopy, Safety

Intervention / Treatment
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* Procedure: anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients are admitted in the institution as ILD, while undefined after thorough history collection, laboratory examination and radiological data. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed Exclusion Criteria: The radiological data indicates non-ILD The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: trachial intubation<br>patient was insert trachial intubation with normal frequency jet ventilation | Procedure: anesthesia<br>* patient was insert trachial intubation or rigid bronchoscopy with ventilation under general anesthesia<br>* Other names: insert rigid bronchoscopy under general anesthesia;|
| Experimental: rigid bronchoscopy<br>patient was insert trachial intubation with high frequency jet ventilation | Procedure: anesthesia<br>* patient was insert trachial intubation or rigid bronchoscopy with ventilation under general anesthesia<br>* Other names: insert rigid bronchoscopy under general anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the fluctuation of heart rate | fluctuation of heart rate during the procedure | 24 hours | 
| the fluctuation of blood pressure | the fluctuation of blood pressure during the procedure | 24 hours | 
| the fluctuation of arterial partial pressure of carbon dioxide | the fluctuation of arterial partial pressure of carbon dioxide during the procedure | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transbronchial Cryobiopsy, anesthesia, tracheal intubation, rigid bronchoscopy, safety, interstitial lung disease