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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04099069
Other study ID # TS20180110
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date June 1, 2020

Study information

Verified date September 2019
Source Guangzhou Institute of Respiratory Disease
Contact Shiyue Li, master
Phone +8613902233925
Email lishiyue@188.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Procedure:
anesthesia
patient was insert trachial intubation or rigid bronchoscopy with ventilation under general anesthesia

Locations

Country Name City State
China The first affilliated hospital of Guanghzhou Medical university Guangzhou ??

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the fluctuation of heart rate fluctuation of heart rate during the procedure 24 hours
Primary the fluctuation of blood pressure the fluctuation of blood pressure during the procedure 24 hours
Primary the fluctuation of arterial partial pressure of carbon dioxide the fluctuation of arterial partial pressure of carbon dioxide during the procedure 24 hours
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