NCT06454513

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

4 years

First QC Date

June 6, 2024

Last Update Submit

June 11, 2024

Conditions

Keywords

Anesthesia methodBronchoscopic biopsyEfficiency research

Outcome Measures

Primary Outcomes (1)

  • Diagnostic efficacy

    The diagnostic positivity rate(%) of transbronchial biopsy under different anesthesia methods between two groups

    baseline

Secondary Outcomes (5)

  • Clinical information

    baseline

  • lesion location (left/right/other)

    baseline

  • lesion size (mm)

    baseline

  • Postoperative complications (hemorrhage or pneumothorax)

    baseline

  • Operation time

    intraoperative

Study Arms (2)

General anesthesia

There all cases in this group where the surgical anesthesia method is general anesthesia

Procedure: general anesthesia

Local anesthesia

There all cases in this group where the surgical anesthesia method is local anesthesia

Interventions

Different anesthesia methods

General anesthesia

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Completed Transbronchial Biopsy;the platelets count and PT, APTT tests were normal, normal ECG, Anesthesiologist evaluation was needed in General anesthesia group.

You may not qualify if:

  • patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), and women who were pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

Respiratory Tract Diseases

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Guanghong G Zhou

    Sichuan Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Respiratory and Critical Care Medicine

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 12, 2024

Study Start

June 1, 2020

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations