UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054909 |
|---|---|
| Receipt number | R000062695 |
| Scientific Title | Evaluation of the usefulness and safety of percutaneous CO2 monitoring for interventional bronchoscopy |
| Date of disclosure of the study information | 2024/07/08 |
| Last modified on | 2025/07/09 16:55:46 |
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Basic information
Public title
Evaluation of the usefulness and safety of percutaneous CO2 monitoring for interventional bronchoscopy
Acronym
Evaluation of the usefulness and safety of percutaneous CO2 monitoring for interventional bronchoscopy
Scientific Title
Evaluation of the usefulness and safety of percutaneous CO2 monitoring for interventional bronchoscopy
Scientific Title:Acronym
Evaluation of the usefulness and safety of percutaneous CO2 monitoring for interventional bronchoscopy
Region
| Japan |
Condition
Condition
Adults 18 years and older requiring interventional bronchoscopy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the usefulness and safety of transcutaneous CO2 values (TcCO2) as an assessment of ventilation and CO2 in interventional bronchoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlations between the values of TcCO2 and PaCO2 in arterial blood gas are evaluated using Pearson's correlation. Two values are measured before the start of TcCO2 monitoring, 7.5 minutes after the start, 15 minutes, 35 minutes, 55 minutes, 75 minutes, and every 30 minutes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Percutaneous CO2 Monitoring is performed by simply attaching a monitoring clip to the ear, and is not invasive, as it is used in regular medical practice.
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
Eligible patients must be adults 18 years of age or older who require interventional bronchoscopy.
Key exclusion criteria
(1) Patients for whom TcCO2 cannot be measured
(2) Patients deemed inappropriate by the principal investigator
(3) Patients whose consent cannot be obtained
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Handa |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Diseases, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
TEL
0449778111
hiroshihstv@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Handa |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Diseases, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
TEL
0449778111
Homepage URL
hiroshihstv@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Marianna Research Council
Address
2-16-1 Sugao Miyamae-ku Kawasaki Kanagawa
Tel
0449778111
k-sienbu.mail@marianna-u.ac.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 | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
IC is performed for patients over 18 years of age with central airway stenosis and severe chronic obstructive pulmonary disease who require interventional pulmonary surgery, regardless of gender, based on the results of various laboratory tests and imaging.
Participant flow
Patients over 18 years of age with central airway stenosis or severe chronic obstructive pulmonary disease, regardless of gender, who require interventional pulmonary surgery will undergo IC regarding the necessity and risks of the procedure based on various examination items and imaging results. When it is determined that a patient is eligible for this study at the time the decision is made to undergo a respiratory intervention, the patient will be informed that he or she is eligible for participation in this study, and consent for participation will be obtained through a written explanation of the study. At the same time, the patient's venous blood samples, arterial blood samples, transcutaneous monitor measurements, respiratory function tests, etc., necessary for the preoperative period and for this study, will be performed.
On the day of surgery, the anesthesiologist will induce general anesthesia, intubate the patient, introduce a ventilator, place a peripheral arterial catheter, and attach a BIS after the patient is transferred to the operating room. The physician will place the TcCO2 monitor on the auricle of either the left or right ear to begin TcCO2 measurement.
Once the anesthesia induction and preparation are complete, and the department is ready to measure TcCO2, the respiratory intervention is initiated. During the procedure, TcCO2 is measured continuously, and arterial blood is collected 7.5, 15, 35, 55, and 75 minutes after the start of TcCO2 monitoring, and every 30 minutes thereafter. After that, arterial blood samples should be collected every 30 minutes until 5 hours have elapsed after the TcCO2 monitor is attached. The TcCO2 monitor will remain in place during the arterial blood collection, and the procedure will be terminated when the TcCO2 monitor is removed.
Adverse events
Nothing
Outcome measures
Analysis method: TcCO2 and PaCO2 in arterial blood gas were measured before, 7.5 minutes after, 15 minutes after, 35 minutes after, 55 minutes after, and 75 minutes after the start of TcCO2 monitoring, and every 30 minutes thereafter, using Pearson's correlation function to evaluate each value.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062695
