AnesthesiaEDAMTBBNCT06454513
Efficacy of Different Anesthesia Methods in Transbronchial Biopsy
An observational study of Anesthesia and Respiratory Diseases, run by Sichuan Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia, Respiratory Diseases, Biopsy
- What is being tested?
- general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who require biopsy to further clarify the nature of lung lesions
Who may be able to join
- Completed Transbronchial Biopsy；the platelets count and PT, APTT tests were normal, normal ECG, Anesthesiologist evaluation was needed in General anesthesia group.
Who cannot join
- patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), and women who were pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Anesthesia, Respiratory Diseases, Biopsy
- Being tested
- general anesthesia
- Keywords
- Anesthesia method, Bronchoscopic biopsy, Efficiency research
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesiaProcedure or surgery
Different anesthesia methods
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | There all cases in this group where the surgical anesthesia method is general anesthesia Receives: Procedure: general anesthesia | |
| Local anesthesia | There all cases in this group where the surgical anesthesia method is local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy
The diagnostic positivity rate(%) of transbronchial biopsy under different anesthesia methods between two groups
Measured: baseline
Secondary outcomes (5)
Clinical information
age（year）, gender(male/female), primary diagnosis(lung cancer/pneumonia or other)
Measured: baseline
lesion location (left/right/other)
Clinical information
Measured: baseline
lesion size (mm)
Clinical information
Measured: baseline
Postoperative complications (hemorrhage or pneumothorax）
Clinical information
Measured: baseline
Operation time
Clinical information
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jun 2020
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guanghong Zhou, Sichuan Provincial People's Hospital
- Investigators
- Guanghong G Zhou, Principal investigator, Sichuan Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454513
- Sponsor's protocol ID
- SichuanPPHGZ03
- Acronym
- EDAMTBB
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration on the Efficacy of Different Anesthesia Methods in Transbronchial Biopsy
- ClinicalTrials.gov ID
- NCT06454513
- Acronym / sponsor ID
- EDAMTBB / SichuanPPHGZ03
- Conditions
- Anesthesia, Respiratory Diseases, Biopsy
- Keywords
- Anesthesia method, Bronchoscopic biopsy, Efficiency research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | – | Procedure: general anesthesiaThere all cases in this group where the surgical anesthesia method is general anesthesia |
| Local anesthesia | – | –There all cases in this group where the surgical anesthesia method is local anesthesia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who require biopsy to further clarify the nature of lung lesions
Key inclusion criteria (1 listed)
- Completed Transbronchial Biopsy；the platelets count and PT, APTT tests were normal, normal ECG, Anesthesiologist evaluation was needed in General anesthesia group.
Key exclusion criteria (1 listed)
- patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), and women who were pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general anesthesiaDifferent anesthesia methods | Procedure or surgery | General anesthesia |
Primary outcome
Diagnostic efficacy
Time frame: baseline
The diagnostic positivity rate(%) of transbronchial biopsy under different anesthesia methods between two groups
5 secondary outcomes
Clinical information
Time frame: baseline
lesion location (left/right/other)
Time frame: baseline
lesion size (mm)
Time frame: baseline
Postoperative complications (hemorrhage or pneumothorax）
Time frame: baseline
Operation time
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guanghong G Zhou principal investigator
Sichuan Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Respiratory Diseases, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.