UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036794
Receipt number R000041918
Scientific Title The influence of changes in tongue pressure on postoperative dysphagia in mechanical ventilated patients after cardiovascular surgery.
Date of disclosure of the study information 2019/05/21
Last modified on 2023/01/01 05:34:52

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Basic information

Public title

The influence of changes in tongue pressure on postoperative dysphagia in mechanical ventilated patients after cardiovascular surgery.

Acronym

The influence of changes in tongue pressure on postoperative dysphagia in mechanical ventilated patients after cardiovascular surgery.

Scientific Title

The influence of changes in tongue pressure on postoperative dysphagia in mechanical ventilated patients after cardiovascular surgery.

Scientific Title:Acronym

The influence of changes in tongue pressure on postoperative dysphagia in mechanical ventilated patients after cardiovascular surgery.

Region

Japan


Condition

Condition

cardiovascular surgery

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Does the change in tongue pressure in patients who require mechanical ventilation after cardiovascular surgery affect the occurrence of postoperative dysphagia?

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Can we predict postoperative dysphagia?

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Open-heart surgery and major vessel surgery
Mechanical ventilation with endotracheal intubation after cardiovascular surgery

Key exclusion criteria

Unconscious
The person in charge of research judged it to be inappropriate

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Toru
Middle name
Last name Yamada

Organization

Toho University Omori Medical Center

Division name

Nursing department

Zip code

143-8541

Address

6-11-1 Omori Nishi, Ota-ku, Tokyo

TEL

03-3762-4151

Email

tooru-yamada@ns.toho-u.ac.jp


Public contact

Name of contact person

1st name Toru
Middle name
Last name Yamada

Organization

Toho University Omori Medical Center

Division name

Nursing department

Zip code

143-8541

Address

Toho University Omori Medical Center

TEL

03-3762-4151

Homepage URL


Email

tooru-yamada@ns.toho-u.ac.jp


Sponsor or person

Institute

Toho University Omori Medical Center

Institute

Department

Personal name



Funding Source

Organization

Toho University Omori Medical Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Toho University Omori Medical Center Ethics Committee Bureau

Address

6-11-1,Omorinishi,Ota-ku,Tokyo

Tel

03-3762-4151

Email

omori.rinri@ext.toho-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

2019 Year 05 Month 21 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ijccm.org/abstractArticleContentBrowse/IJCCM/64/26/12/31158/abstractArticle/Article

Number of participants that the trial has enrolled

68

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Currently writing a paper.

Date of the first journal publication of results

2022 Year 12 Month 08 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 04 Month 24 Day

Date of IRB

2018 Year 07 Month 25 Day

Anticipated trial start date

2018 Year 07 Month 25 Day

Last follow-up date

2020 Year 07 Month 30 Day

Date of closure to data entry

2020 Year 08 Month 31 Day

Date trial data considered complete

2020 Year 08 Month 31 Day

Date analysis concluded

2020 Year 08 Month 31 Day


Other

Other related information

Prospective observational research.
The tongue pressure of the patient is measured preoperatively, 6 hours, 3 days and 7 days after extubation. As for indicators of dysphagia after extubation, the results of swallowing function evaluation and clinical findings of dysphagia are extracted.


Management information

Registered date

2019 Year 05 Month 20 Day

Last modified on

2023 Year 01 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041918


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name