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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036794
Receipt No. 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 2019/05/20

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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
Institute Toho University Omori Medical Center
Institute
Department

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
Address 6-11-1,Omorinishi,Ota-ku,Tokyo
Tel 03-3762-4151
Email tooru-yamada@ns.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 Unpublished

Result
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

Progress
Recruitment status Enrolling by invitation
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 09 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.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


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