UMIN-ICDS Clinical Trial

Public title

Cuff-Leak Test Results in Patients Requiring Prolonged Sedation After General Anesthesia: A Prospective Observational Study

Acronym

Cuff-Leak Test Results in Patients Requiring Prolonged Sedation After General Anesthesia: A Prospective Observational Study

Scientific Title

Cuff-Leak Test Results in Patients Requiring Prolonged Sedation After General Anesthesia: A Prospective Observational Study

Scientific Title:Acronym

Cuff-Leak Test Results in Patients Requiring Prolonged Sedation After General Anesthesia: A Prospective Observational Study

Region

Japan

Condition

Congenital disorders in children causing facial hypoplasia, cervical myelopathy in adults

Classification by specialty

Orthopedics

Plastic surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To observe changes in the cuff-leak test results over time in the intensive care unit until extubation in patients requiring prolonged sedation following surgery under general anesthesia

Basic objectives2

Others

Basic objectives -Others

To determine the optimal timing for extubation in the above patient group based on the results of the cuff-leak test

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Cuff-leak pressure(CLP), Cuff-leak volume(CLV)

Key secondary outcomes

Macroscopic findings around the larynx, post-extubation stridor (PES), and reintubation

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Eligible participants are those who meet either criterion 1) or 2) below.
1) Patients under 18 years of age who undergo facial bone reconstruction surgery under general anesthesia at this facility and are placed on intubated mechanical ventilation in the intensive care unit postoperatively; for those under 16 years of age, the study must be explained to the participant using an assent form to confirm their willingness to participate, and the study must also be explained to the legal guardian using a consent form to obtain written consent; For patients aged 16 years or older but under 18 years, those for whom both the research subject and the surrogate have been informed using a research consent form and written consent has been obtained;
2) Patients aged 18 years or older who undergo cervical anterior fusion under general anesthesia at this facility and are placed on intubated mechanical ventilation in the intensive care unit postoperatively, provided that, after receiving a thorough explanation regarding participation in this study, written consent has been obtained from the patient based on their own free will and full understanding.

Key exclusion criteria

1) Cases where consent was not obtained
2) Cases following tracheostomy
3) Other cases deemed inappropriate by the researchers

Target sample size

15

Name of lead principal investigator

1st name	Takayuki
Middle name
Last name	Yamada

Organization

Chiba university hospital

Division name

Department of Anesthesiology, Pain and Palliative Care Medicine

Zip code

2608677

Address

1-8-1 Inohana, Chuo-Ku, Chiba 260-8670, Japan

TEL

0432227171

Email

chwa1627@chiba-u.jp

Name of contact person

1st name	Takayuki
Middle name
Last name	Yamada

Organization

Chiba university hospital

Division name

Department of Anesthesiology, Pain and Palliative Care Medicine

Zip code

2608677

Address

1-8-1 Inohana, Chuo-Ku, Chiba 260-8670, Japan

TEL

0432227171

Homepage URL

Email

chwa1627@chiba-u.jp

Institute

Chiba University Hospital

Institute

Department

Personal name

Organization

Chiba University Hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Chiba University Hospital

Address

1-8-1 Inohana, Chuo-Ku, Chiba 260-8670, Japan

Tel

0432227171

Email

chwa1627@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

2026

Year

08

Month

29

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

2026

Year

08

Month

17

Day

Date of IRB

2026

Year

08

Month

21

Day

Anticipated trial start date

2026

Year

08

Month

28

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Nothing in particular

Registered date

2026

Year

08

Month

28

Day

Last modified on

2026

Year

08

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071812