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

Sponsor

Guangzhou Institute of Respiratory Disease (Other)

Overall Status

Unknown status

CT.gov ID

NCT04099069

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

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 Names: 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 Names: insert rigid bronchoscopy under general anesthesia

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 Names:

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 Names:

insert rigid bronchoscopy under general anesthesia

Outcome Measures

Primary Outcome Measures

the fluctuation of heart rate [24 hours]
fluctuation of heart rate during the procedure
the fluctuation of blood pressure [24 hours]
the fluctuation of blood pressure during the procedure
the fluctuation of arterial partial pressure of carbon dioxide [24 hours]
the fluctuation of arterial partial pressure of carbon dioxide during the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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