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Status unknownNCT04099069Updated Sep 23, 2019

The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy

An interventional study of anesthesia in Transbronchial Cryobiopsy, Anesthesia and Tracheal Intubation, sponsored by Guangzhou Institute of Respiratory Disease. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-23.

Sponsored by Guangzhou Institute of Respiratory Disease · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Transbronchial Cryobiopsy
  • Anesthesia
  • Tracheal Intubation
  • Rigid Bronchoscopy
  • Safety

Keywords

  • Transbronchial Cryobiopsy
  • anesthesia
  • tracheal intubation
  • rigid bronchoscopy
  • safety
  • interstitial lung disease
03

In context

Lead sponsor

Guangzhou Institute of Respiratory Disease is the lead sponsor of 96 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The patients are admitted in the institution as ILD, while undefined after thorough history collection, laboratory examination and radiological data.
  2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
  3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed

Exclusion criteria

Exclusion Criteria:

  1. The radiological data indicates non-ILD
  2. The clinical examinations mentioned above are not completed.
  3. The patient cannot endure or does not agree the procedure.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    trachial intubation

    patient was insert trachial intubation with normal frequency jet ventilation

    Procedure: anesthesia

  • Experimental
    rigid bronchoscopy

    patient was insert trachial intubation with high frequency jet ventilation

    Procedure: anesthesia

Interventions

  • Procedureanesthesia

    patient was insert trachial intubation or rigid bronchoscopy with ventilation under general anesthesia

    Also known as: insert rigid bronchoscopy under general anesthesia

06

What researchers measure

Primary outcomes

  1. the fluctuation of heart rate

    fluctuation of heart rate during the procedure

    Time frame: 24 hours

  2. the fluctuation of blood pressure

    the fluctuation of blood pressure during the procedure

    Time frame: 24 hours

  3. the fluctuation of arterial partial pressure of carbon dioxide

    the fluctuation of arterial partial pressure of carbon dioxide during the procedure

    Time frame: 24 hours

07

Study locations

1 site
  • The first affilliated hospital of Guanghzhou Medical university
    Guangzhou, 广东 510120, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04099069
Lead sponsor
Guangzhou Institute of Respiratory Disease
Responsible party
ShiYue Li (Director of the Respiratory department, Guangzhou Institute of Respiratory Disease) — Principal investigator
First posted
Sep 23, 2019
Start date
Oct 1, 2019 (estimated)
Primary completion
Jun 1, 2020 (estimated)
Completion
Jun 1, 2020 (estimated)
Last update
Sep 23, 2019

Study contacts

Shiyue Li, master
Contact
lishiyue@188.com
+8613902233925
Xiaobo Chen, master
Contact
xiaobo-win@163.com
+8613751721744

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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