UMIN-ICDS Clinical Trial

Public title

Relationship Between Respiratory Stability Time and Recovery After General Anesthesia: A Prospective Observational Study in Patients Undergoing TAVR

Acronym

RST-TAVR Recovery Study

Scientific Title

Association Between Respiratory Stability Time and Recovery After General Anesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement: A Prospective Observational Study

Scientific Title:Acronym

RSTAVR Study

Region

Japan

Condition

Patients with aortic stenosis undergoing transcatheter aortic valve replacement

Classification by specialty

Cardiology	Anesthesiology	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to prospectively investigate the association between preoperative Respiratory Stability Time (RST) and postoperative delirium in patients undergoing transcatheter aortic valve replacement (TAVR) under general anesthesia.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of postoperative delirium within 7 days after surgery or during hospitalization, assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).

Key secondary outcomes

Postoperative delirium assessed using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
Gait speed
Six-minute walk distance
Length of ICU/CCU stay
Length of hospital stay

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

Patients aged 18 years or older who are scheduled to undergo transcatheter aortic valve replacement (TAVR) under general anesthesia at Toyama University Hospital, in whom preoperative Respiratory Stability Time (RST) can be measured, and from whom written informed consent can be obtained from the patient or a legally authorized representative.

Key exclusion criteria

Patients meeting any of the following criteria will be excluded:

Inability to undergo preoperative Respiratory Stability Time (RST) measurement
Inability to obtain information required for postoperative delirium assessment
Inability to obtain written informed consent from the patient or a legally authorized representative
Patients judged by the principal investigator to be unsuitable for participation in this study

Target sample size

80

Name of lead principal investigator

1st name	Hisakatsu
Middle name
Last name	Ito

Organization

Toyama University Hospital

Division name

Department of Anesthesiology

Zip code

9300194

Address

Sugitani 2630, Toyama, Toyama, Japan

TEL

0764347377

Email

hisa@med.u-toyama.ac.jp

Name of contact person

1st name	Hisakatsu
Middle name
Last name	Ito

Organization

Toyama University Hospital

Division name

Department of Anesthesiology

Zip code

9300194

Address

Sugitani 2630, Toyama, Toyama, Japan

TEL

0764347377

Homepage URL

Email

hisa@med.u-toyama.ac.jp

Institute

University of Toyama

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Research Management Center, Toyama University Hospital

Address

2630 Sugitani, Toyama 930-0194, Japan

Tel

076-434-2868

Email

hisa@med.u-toyama.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

富山県

Institutions

Date of disclosure of the study information

2026

Year

06

Month

08

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

05

Month

14

Day

Date of IRB

2026

Year

05

Month

21

Day

Anticipated trial start date

2026

Year

07

Month

01

Day

Last follow-up date

2027

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a single-center prospective observational study of patients undergoing transcatheter aortic valve replacement (TAVR) under general anesthesia at Toyama University Hospital. Preoperative Respiratory Stability Time (RST) will be measured using a non-contact sensor, and its association with postoperative delirium will be investigated. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or during hospitalization. Secondary outcomes include delirium assessed using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM), gait speed, six-minute walk distance, length of ICU/CCU stay, and length of hospital stay. No study-related intervention will be performed, and all analyses will be conducted using data obtained during routine clinical care.

Registered date

2026

Year

06

Month

08

Day

Last modified on

2026

Year

06

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070748