Efficacy of Different Anesthesia Methods in Transbronchial Biopsy (EDAMTBB)

Exploration on the Efficacy of Different Anesthesia Methods in Transbronchial Biopsy

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Respiratory Diseases; Biopsy
• Intervention / Treatment: Procedure: general anesthesia

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who require biopsy to further clarify the nature of lung lesions

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General anesthesia; There all cases in this group where the surgical anesthesia method is general anesthesia	Procedure: general anesthesia; Different anesthesia methods
Local anesthesia; There all cases in this group where the surgical anesthesia method is local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic efficacy	The diagnostic positivity rate(%) of transbronchial biopsy under different anesthesia methods between two groups	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical information	age（year）, gender(male/female), primary diagnosis(lung cancer/pneumonia or other)	baseline
lesion location (left/right/other)	Clinical information	baseline
lesion size (mm)	Clinical information	baseline
Postoperative complications (hemorrhage or pneumothorax）	Clinical information	baseline
Operation time	Clinical information	intraoperative

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital
• Investigators: Principal Investigator: Guanghong G Zhou, Sichuan Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Bronchoscopic biopsy; Anesthesia method; Efficiency research
• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SichuanPPHGZ03

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