UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053984 |
|---|---|
| Receipt number | R000061620 |
| Scientific Title | Risk Factors for Hypercarbonemia Using Percutaneous Blood Gas Monitoring in Nonintubated and Intubated Flexible Bronchoscopy; A Prospective Observational Study. |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/27 12:26:43 |
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Basic information
Public title
Risk Factors for Elevated Carbon Dioxide Levels in Bronchoscopy Using Percutaneous Monitoring; A Prospective Observational Study.
Acronym
Risk Factors for Elevated Carbon Dioxide Levels in Bronchoscopy; A Prospective Observational Study.
Scientific Title
Risk Factors for Hypercarbonemia Using Percutaneous Blood Gas Monitoring in Nonintubated and Intubated Flexible Bronchoscopy; A Prospective Observational Study.
Scientific Title:Acronym
Risk Factors for Hypercarbonemia in Nonintubated and Intubated Flexible Bronchoscopy; A Prospective Observational Study.
Region
| Japan |
Condition
Condition
Respiratory disease requiring nonintubated and intubated flexible bronchoscopy.
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the advent of cryobiopsy in recent years, intubated bronchoscopy procedures with higher risk for hypoventilation have increased. However, few medical institutions monitor partial pressure of arterial carbon dioxide (PaCO2) or transcutaneous partial pressure of carbon dioxide (tcPCO2) during bronchoscopy procedures. A few reports have investigated tcPCO2 elevation and its risk during nonintubated bronchoscopy, but none during intubated bronchoscopy. The monitoring is very important for medical safety.
The objectives of this study is to clarify the risk factors for patients with severe hypercapnia by monitoring tcPCO2 with a transcutaneous blood gas monitor placed during nonintubated and intubated bronchoscopy.
Basic objectives2
Others
Basic objectives -Others
a
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The highest tcPCO2 during bronchoscopy.
Key secondary outcomes
Differences in clinical characteristics between high tcPCO2 group and low tcPCO2 group.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 18 years of age or older at the time of consent.
2) Patients who undergo nonintubated and intubated flexible bronchoscopy in our department.
3) Patients who have been fully informed of the study and who have given their free and voluntary written consent based on their full understanding of the study.
Key exclusion criteria
1) Patients with contraindications to flexible bronchoscopy
2) Patients with contraindications to midazolam or lidocaine administration
3) Patients who are judged by the principal investigator or subinvestigator to be unsuitable for the safe conduct of this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Ikari |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL
043-222-7171
junikari@chiba-u.jp
Public contact
Name of contact person
| 1st name | Ryutaro |
| Middle name | |
| Last name | Hirama |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL
043-222-7171
Homepage URL
ryu.154038@gmail.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital Observational Research Ethics Review Board
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
Tel
043-222-7171
hsp-kansaturinri@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect information on the following patients.
A) Information before bronchoscopy
Patient Background
American Society of Anesthesiologists-Performance Status (ASA-PS)
Mallampati Classification
Respiratory diseases to be examined
Questionnaire (daily snoring, fatigue, sleep apnea)
Neck circumference length
Vital signs at rest
Arterial blood gases at rest
Blood tests
Imaging
Respiratory function tests
B) Information during bronchoscopy
Trend in tcPCO2 during the examination
Trend in vital signs during the examination
Richmond Agitation-Sedation Scale (RASS) at the beginning and end of the examination
Details of procedures performed
Dose of analgesic and sedative drugs administered during the examination
Time required for the examination
Adverse events and their responses
Post-examination diagnosis
Management information
Registered date
| 2024 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061620
