UMIN-ICDS Clinical Trial

Public title

A study to predict breathing deterioration after removal of a breathing tube using ventilator measurements and lung ventilation imaging

Acronym

C6-EIT Extubation Study

Scientific Title

Prediction of post-extubation respiratory failure using HAMILTON-C6-derived respiratory drive and breathing-pattern indices and electrical impedance tomography in patients who pass a spontaneous breathing trial: a prospective single-center study

Scientific Title:Acronym

C6-EIT Extubation Study

Region

Japan

Condition

Critically ill adults scheduled for liberation from invasive mechanical ventilation and extubation

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine, in invasively ventilated adults who successfully complete a spontaneous breathing trial (SBT) and are scheduled for extubation, whether the change in |P0.1| x rapid shallow breathing index (RSBI) from the early to the late phase of the SBT measured by HAMILTON-C6 and the absolute difference between ventral and dorsal ventilation distribution measured by electrical impedance tomography (EIT) 1-5 minutes after SBT initiation are associated with unplanned rescue noninvasive positive-pressure ventilation (NPPV) or reintubation due to respiratory deterioration within 72 hours after extubation, and to explore the predictive value of combining these indices.

Basic objectives2

Others

Basic objectives -Others

Risk prediction and exploration of predictors of post-extubation respiratory failure

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Occurrence of the composite outcome of unplanned rescue NPPV initiation or reintubation due to respiratory deterioration within 72 hours after extubation. Planned prophylactic NPPV or high-flow nasal cannula (HFNC) therapy alone will not be counted as an event.

Key secondary outcomes

Reintubation within 48 hours and within 7 days after extubation.

Unplanned rescue NPPV without reintubation within 72 hours after extubation.

Occurrence of objectively defined post-extubation respiratory failure within 72 hours and time from extubation to its onset.

Associations between the primary outcome and HAMILTON-C6-derived indices measured 1-5 and 25-30 minutes after SBT initiation, including |P0.1|, RSBI, respiratory rate, tidal volume, minute ventilation, and Cstat/predicted body weight, as well as their changes during the SBT.

Associations between the primary outcome and EIT-derived indices during the SBT, including the absolute ventral-to-dorsal ventilation distribution difference, dorsal ventilation fraction, center of ventilation, global inhomogeneity index, changes in end-expiratory lung impedance, and pendelluft, as well as their changes over time.

Associations of cough strength, the number of suctioning procedures during the 6 hours before extubation, and secretion burden with the primary outcome.

ICU length of stay, hospital length of stay, tracheostomy, ICU mortality, and in-hospital mortality.

Adverse events and device malfunctions related to EIT belt placement or research data acquisition.

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

Adults aged 18 years or older.

Receiving invasive mechanical ventilation for at least 24 hours in the intensive care unit of Yamagata University Hospital.

Completion of a spontaneous breathing trial (SBT) lasting at least 30 minutes according to the institutional standard procedure, with the treating physician determining that the SBT was successful.

Extubation on the same day has been decided by the treating physician and is expected to occur approximately within 2 hours after the study measurements.

The SBT can be performed using a HAMILTON-C6 ventilator with software version 1.2.3 or later, and the required parameters, including P0.1, respiratory rate, and tidal volume, can be recorded.

Written informed consent can be obtained from the participant or a legally acceptable representative.

If a patient has multiple extubation opportunities, only the first eligible extubation will generally be enrolled.

Key exclusion criteria

Presence of a tracheostomy or planned tracheostomy after extubation.

A treatment-limitation decision specifying that reintubation will not be performed.

A significant endotracheal tube leak, bronchopleural fistula, flow-sensor malfunction, or another condition that may make HAMILTON-C6 measurements of ventilation or respiratory mechanics inaccurate.

Severe skin lesions at the EIT belt site, chest-wall anatomy, surgical wounds, medical devices, or other conditions preventing appropriate EIT measurement, or any contraindication to the EIT device.

Unstable hemodynamics, uncontrolled arrhythmia, persistent severe hypoxemia, or another condition making the study measurements unsafe.

Planned prophylactic NPPV immediately after extubation is considered mandatory, making it difficult to distinguish prophylactic from rescue NPPV. Routine planned HFNC use alone is not an exclusion criterion.

Current or possible pregnancy.

Any other condition considered unsuitable for study participation by the treating physician or principal investigator.

Target sample size

150

Name of lead principal investigator

1st name	Tadahiro
Middle name
Last name	Kobayashi

Organization

Yamagata University Faculty of Medicine

Division name

Department of Emergency and Critical Care Medicine

Zip code

990-9585

Address

2-2-2 Iida-Nishi, Yamagata City, Yamagata

TEL

023-628-5422

Email

ta-kobayashi@med.id.yamagata-u.ac.jp

Name of contact person

1st name	Tadahiro
Middle name
Last name	Kobayashi

Organization

Yamagata University Faculty of Medicine

Division name

Department of Emergency and Critical Care Medicine

Zip code

9909585

Address

2-2-2 Iida-Nishi, Yamagata, Yamagata-pref, Japan

TEL

0236285422

Homepage URL

Email

ta-kobayashi@med.id.yamagata-u.ac.jp

Institute

Yamagata University

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Yamagata University Faculty of Medicine Ethics Committee

Address

2-2-2 Iida-Nishi, Yamagata, 990-9585, Japan

Tel

023-628-5047

Email

yu-ikekenkyu@jm.kj.yamagata-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

山形大学医学部附属病院（山形県）

Date of disclosure of the study information

2026

Year

10

Month

16

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

Preinitiation

Date of protocol fixation

2026

Year

09

Month

15

Day

Date of IRB

2026

Year

09

Month

28

Day

Anticipated trial start date

2026

Year

11

Month

15

Day

Last follow-up date

2029

Year

10

Month

31

Day

Date of closure to data entry

2029

Year

10

Month

31

Day

Date trial data considered complete

2029

Year

12

Month

31

Day

Date analysis concluded

2030

Year

03

Month

31

Day

Other related information

This is a prospective, single-center, exploratory observational cohort study. Consecutive adult patients who have received invasive mechanical ventilation for at least 24 hours in the ICU of Yamagata University Hospital, successfully complete a standard spontaneous breathing trial (SBT), and are scheduled for same-day extubation will be enrolled. During the SBT performed as part of routine clinical care, HAMILTON-C6-derived indices of respiratory drive, breathing pattern, and respiratory mechanics and regional ventilation distribution measured by electrical impedance tomography (EIT) will be recorded. The study will not alter the SBT settings or duration, timing of extubation, or post-extubation treatment. The primary exposure variables are the change in |P0.1| x RSBI between 1-5 and 25-30 minutes after SBT initiation and the absolute difference between ventral and dorsal ventilation distribution measured by EIT at 1-5 minutes after SBT initiation. The primary outcome is unplanned rescue NPPV or reintubation due to respiratory deterioration within 72 hours after extubation. Planned prophylactic NPPV or HFNC alone will not be counted as an event. Eligible patients will be enrolled consecutively, with a target sample size of 150.

Registered date

2026

Year

10

Month

15

Day

Last modified on

2026

Year

10

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072458