NCT04099069

Brief Summary

to evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

May 28, 2019

Last Update Submit

September 19, 2019

Conditions

Keywords

Transbronchial Cryobiopsyanesthesiatracheal intubationrigid bronchoscopysafetyinterstitial lung disease

Outcome Measures

Primary Outcomes (3)

  • the fluctuation of heart rate

    fluctuation of heart rate during the procedure

    24 hours

  • the fluctuation of blood pressure

    the fluctuation of blood pressure during the procedure

    24 hours

  • the fluctuation of arterial partial pressure of carbon dioxide

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

    24 hours

Study Arms (2)

trachial intubation

PLACEBO COMPARATOR

patient was insert trachial intubation with normal frequency jet ventilation

Procedure: anesthesia

rigid bronchoscopy

EXPERIMENTAL

patient was insert trachial intubation with high frequency jet ventilation

Procedure: anesthesia

Interventions

anesthesiaPROCEDURE

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

Also known as: insert rigid bronchoscopy under general anesthesia
rigid bronchoscopytrachial intubation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affilliated hospital of Guanghzhou Medical university

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Central Study Contacts

Shiyue Li, master

CONTACT

Xiaobo Chen, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Respiratory department

Study Record Dates

First Submitted

May 28, 2019

First Posted

September 23, 2019

Study Start

October 1, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations