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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06454513
Other study ID # SichuanPPHGZ03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date June 1, 2024

Study information

Verified date June 2024
Source Sichuan Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study investigates the efficacy of different anesthesia methods (general anesthesia with laryngeal mask airway and local nebulized anesthesia) for transbronchial biopsy using an electronic bronchoscope. The study retrospectively analyzed cases of transbronchial biopsy performed at the Respiratory Endoscopy Center of Sichuan Provincial People's Hospital from June 5, 2020, to June 5, 2024. Data collected included age, gender, primary diagnosis, anesthesia method, biopsy method, operation time (excluding general anesthesia and laryngeal mask airway placement time), lesion location and size, pathological results, and follow-up status.


Description:

General anesthesia and local anesthesia are the primary anesthesia methods for interventional respiratory endoscopy. While general anesthesia offers greater comfort, it carries anesthesia-related risks. Local anesthesia, on the other hand, provides a relatively low surgical risk and cost-effectiveness. However, there is limited research on whether its diagnostic value is inferior to that of general anesthesia.This study investigates the efficacy of the two anesthesia methods (general anesthesia with laryngeal mask airway and local nebulized anesthesia) for transbronchial biopsy. The study retrospectively analyzed cases of transbronchial biopsy performed at the Respiratory Endoscopy Center of Sichuan Provincial People's Hospital from June 5, 2020, to June 5, 2024. Data collected included age, gender, primary diagnosis, anesthesia method, biopsy method(forcep/cryobiopsy), operation time (excluding general anesthesia and laryngeal mask airway placement time), lesion location and size, pathological results, and follow-up status(pneumothorax、hemorrhage).


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Completed Transbronchial Biopsy;the platelets count and PT, APTT tests were normal, normal ECG, Anesthesiologist evaluation was needed in General anesthesia group. Exclusion Criteria: - patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), and women who were pregnant.

Study Design


Intervention

Procedure:
general anesthesia
Different anesthesia methods

Locations

Country Name City State
China Sichuan Provincial People's Hospital Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic efficacy The diagnostic positivity rate(%) of transbronchial biopsy under different anesthesia methods between two groups baseline
Secondary Clinical information age(year), gender(male/female), primary diagnosis(lung cancer/pneumonia or other) baseline
Secondary lesion location (left/right/other) Clinical information baseline
Secondary lesion size (mm) Clinical information baseline
Secondary Postoperative complications (hemorrhage or pneumothorax) Clinical information baseline
Secondary Operation time Clinical information intraoperative
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