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

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

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

Study Overview

• Status: Unknown
• Conditions: Anesthesia; Safety; Tracheal Intubation; Transbronchial Cryobiopsy; Rigid Bronchoscopy
• Intervention / Treatment: Procedure: anesthesia

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • 广东
    • Guangzhou, 广东, China, 510120
      • The first affilliated hospital of Guanghzhou Medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: anesthesia; safety; interstitial lung disease; tracheal intubation; Transbronchial Cryobiopsy; rigid bronchoscopy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: TS20180110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No