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

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ClinicalTrials.gov Identifier: NCT04099069
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
ShiYue Li, Guangzhou Institute of Respiratory Disease

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

Condition or disease Intervention/treatment Phase
Transbronchial Cryobiopsy Anesthesia Tracheal Intubation Rigid Bronchoscopy Safety Procedure: anesthesia Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy:A Prospective, Randomized, Controlled Trial
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Arm Intervention/treatment
Placebo Comparator: trachial intubation
patient was insert trachial intubation with normal frequency jet ventilation
Procedure: anesthesia
patient was insert trachial intubation or rigid bronchoscopy with ventilation under general anesthesia
Other Name: insert rigid bronchoscopy under general anesthesia

Experimental: rigid bronchoscopy
patient was insert trachial intubation with high frequency jet ventilation
Procedure: anesthesia
patient was insert trachial intubation or rigid bronchoscopy with ventilation under general anesthesia
Other Name: insert rigid bronchoscopy under general anesthesia




Primary Outcome Measures :
  1. the fluctuation of heart rate [ Time Frame: 24 hours ]
    fluctuation of heart rate during the procedure

  2. the fluctuation of blood pressure [ Time Frame: 24 hours ]
    the fluctuation of blood pressure during the procedure

  3. the fluctuation of arterial partial pressure of carbon dioxide [ Time Frame: 24 hours ]
    the fluctuation of arterial partial pressure of carbon dioxide during the procedure



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patients are admitted in the institution as ILD, while undefined after thorough history collection, laboratory examination and radiological data.
  2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
  3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed

Exclusion Criteria:

  1. The radiological data indicates non-ILD
  2. The clinical examinations mentioned above are not completed.
  3. The patient cannot endure or does not agree the procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099069


Contacts
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Contact: Shiyue Li, master +8613902233925 lishiyue@188.com
Contact: Xiaobo Chen, master +8613751721744 xiaobo-win@163.com

Locations
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China, 广东
The first affilliated hospital of Guanghzhou Medical university Not yet recruiting
Guangzhou, 广东, China, 510120
Contact: Xiaobo Chen, master    +8613751721744    xiaobo-win@163.com   
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease

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Responsible Party: ShiYue Li, Director of the Respiratory department, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT04099069     History of Changes
Other Study ID Numbers: TS20180110
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ShiYue Li, Guangzhou Institute of Respiratory Disease:
Transbronchial Cryobiopsy
anesthesia
tracheal intubation
rigid bronchoscopy
safety
interstitial lung disease
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs