UMIN-ICDS Clinical Trial

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

Respiratory disease requiring nonintubated and intubated flexible bronchoscopy.

Classification by specialty

Pneumology

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The highest tcPCO2 during bronchoscopy.

Key secondary outcomes

Differences in clinical characteristics between high tcPCO2 group and low tcPCO2 group.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

junikari@chiba-u.jp

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

Email

ryu.154038@gmail.com

Institute

Chiba University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Chiba University Hospital Observational Research Ethics Review Board

Address

1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan

Tel

043-222-7171

Email

hsp-kansaturinri@chiba-u.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

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/icdr_e/ctr_view.cgi?recptno=R000061620