Efficacy of Different Anesthesia Methods in Transbronchia... | NCT06454513

Studies
Efficacy of Different Anesthesia Methods in Transbronchial Biopsy

NCT06454513

Sponsor

Sichuan Provincial People's Hospital

Status

Completed

Last Update Posted

Jun 12, 2024Actual

Enrollment

800Actual

Phase

Not provided

Conditions

Anesthesia
Respiratory Diseases
Biopsy

Interventions

general anesthesia

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Jun 1, 2024Actual

Completion Date

Jun 1, 2024Actual

First Submitted Date

Jun 6, 2024

First Submission Date that Met QC Criteria

Jun 11, 2024

First Posted Date

Jun 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2024

Last Update Posted Date

Jun 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guanghong Zhou, Department of Respiratory and Critical Care Medicine, Sichuan Provincial People's HospitalPrincipal Investigator

Lead Sponsor

Sichuan Provincial People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
general anesthesia	Procedure	Different anesthesia methods	General anesthesia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guanghong G Zhou	Sichuan Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sichuan Provincial People's Hospital		Chengdu	Sichuan	610072	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012140	Respiratory Tract Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000768	Anesthesia, General

Ancestor Terms

ID	Term
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided