Transbronchial CryobiopsyNCT04099069
The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy
A study testing anesthesia in people with Transbronchial Cryobiopsy and Anesthesia, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
to evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transbronchial Cryobiopsy, Anesthesia, Tracheal Intubation
- What is being tested?
- anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Jun 2020
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients are admitted in the institution as ILD, while undefined after thorough history collection, laboratory examination and radiological data.
- Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
- Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed
Who cannot join
- The radiological data indicates non-ILD
- The clinical examinations mentioned above are not completed.
- The patient cannot endure or does not agree the procedure.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affilliated hospital of Guanghzhou Medical university
Guangzhou, Guangdong, 510120
Xiaobo Chen, master, +8613751721744, xiaobo-win@163.com
About this study
Official title: The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy:A Prospective, Randomized, Controlled Trial
to evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy.
Read the detailed description
To evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy. Comparing the difference between two groups in the operating duration, extubation duration, total anesthesia time, heart rate, blood pressure and arterial blood gas analysis. This is a prospective, randomized, controlled trial.
- Being tested
- anesthesia
- Keywords
- Transbronchial Cryobiopsy, anesthesia, tracheal intubation, rigid bronchoscopy, safety, interstitial lung disease
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesiaProcedure or surgery
Also called insert rigid bronchoscopy under general anesthesia
patient was insert trachial intubation or rigid bronchoscopy with ventilation under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| trachial intubation | Placebo comparator | patient was insert trachial intubation with normal frequency jet ventilation Receives: Procedure: anesthesia |
| rigid bronchoscopy | Experimental | patient was insert trachial intubation with high frequency jet ventilation Receives: Procedure: anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the fluctuation of heart rate
fluctuation of heart rate during the procedure
Measured: 24 hours
the fluctuation of blood pressure
the fluctuation of blood pressure during the procedure
Measured: 24 hours
the fluctuation of arterial partial pressure of carbon dioxide
the fluctuation of arterial partial pressure of carbon dioxide during the procedure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transbronchial CryobiopsyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099069
- Sponsor's protocol ID
- TS20180110
- Status last verified
- Sep 2019
- First submitted
- 28 May 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy:A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04099069
- Acronym / sponsor ID
- TS20180110
- Keywords
- Transbronchial Cryobiopsy, anesthesia, tracheal intubation, rigid bronchoscopy, safety, interstitial lung disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 23 Sep 2019 (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.
to evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy.
Detailed description
To evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy. Comparing the difference between two groups in the operating duration, extubation duration, total anesthesia time, heart rate, blood pressure and arterial blood gas analysis. This is a prospective, randomized, controlled trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trachial intubation | Placebo comparator | Procedure: anesthesiapatient was insert trachial intubation with normal frequency jet ventilation |
| rigid bronchoscopy | Experimental | Procedure: anesthesiapatient was insert trachial intubation with high frequency jet ventilation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients are admitted in the institution as ILD, while undefined after thorough history collection, laboratory examination and radiological data.
- Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
- Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed
Key exclusion criteria (3 listed)
- The radiological data indicates non-ILD
- The clinical examinations mentioned above are not completed.
- The patient cannot endure or does not agree the procedure.
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 |
|---|---|---|
| anesthesiaAlso: insert rigid bronchoscopy under general anesthesiapatient was insert trachial intubation or rigid bronchoscopy with ventilation under general anesthesia | Procedure or surgery | rigid bronchoscopy, trachial intubation |
Primary outcome
the fluctuation of heart rate
Time frame: 24 hours
fluctuation of heart rate during the procedure
the fluctuation of blood pressure
Time frame: 24 hours
the fluctuation of blood pressure during the procedure
the fluctuation of arterial partial pressure of carbon dioxide
Time frame: 24 hours
the fluctuation of arterial partial pressure of carbon dioxide during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Transbronchial Cryobiopsy
Not yet recruiting
TBLC vs NIVATS in Interstitial Lung Disease
Interstitial Lung Diseases (ILD)
Active, not recruiting
Diagnostic Value of EBUS-Guided Transbronchial Mediastinal Cryobiopsy Versus Conventional Bronchoscopic Approaches for Stage I/II Sarcoidosis
Sarcoidosis, Pulmonary
Active, not recruitingPhase 3
Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy
Hemorrhage Lung, Endobronchial Mass
Not yet recruitingObservational study
Safety of Bronchoscopy in Patients With Interstitial Lung Disease
Interstitial Lung Disease (ILD), Bronchoscopy
Recruiting
Defining a Technique for the Use of Cryogenic Catheters for Biopsy and Ablation for the Diagnostic and Treatment of Pulmonary Lesions: An Ex-Vivo Human Lung Model Study.
Lung Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anesthesia in people with Transbronchial Cryobiopsy and Anesthesia, run by Guangzhou Institute of Respiratory Disease 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyue Li, master (+8613902233925, lishiyue@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the fluctuation of heart rate (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 23 Sep 2019.