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Japanese

June. 13, 2023

July. 20, 2023

jRCT1032230133

Tongue Exercise Program for Postoperative Cardiovascular Surgery Patients on Respirators for More Than 48 Hours
Comparison between intervention and non-intervention groups

Examination of Tongue Exercise Programs

Hyakkoku Hitomi

Showa University Koto Toyosu Hospital

5-1-38Toyosu Kotouku Tokyouto

+81-3-6204-6000

hhitomi@cmed.showa-u.ac.jp

Hyakkoku Hitomi

Showa University Koto Toyosu Hospital

5-1-38Toyosu Kotouku Tokyouto

+81-3-6204-6000

hhitomi@cmed.showa-u.ac.jp

Recruiting

June. 13, 2023

60

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

screening

1) Patients with valvular heart disease and scheduled to undergo cardiac bypass surgery who are hospitalized at Showa University Koto Toyosu Hospital, Department of Cardiovascular Surgery
2) Patients who are 18 years of age or older at the time consent is obtained
3) Patients who have given written consent to participate in this study.
4) Patients scheduled to be on a ventilator for more than 48 hours

1) Patients with cognitive decline at the time of admission
2) Patients for whom it is difficult to perform the tongue function training and examination in this study for the following reasons
(1) Patients with tongue function impairment at the time of admission
(2)Patients with oral disorders at the time of admission
(3) Preoperative starting value of tongue pressure is less than 15 kPa
(4) Patients who are unable to assume the sitting position for training and measurement (sitting on the bed or sitting on the edge of the bed).
(5) Patients who have difficulty in proper training and measurement due to a strong vomiting reflex
(6) Patients who have difficulty in communicating with the investigators and understanding the appropriate training methods.
3) Patients deemed ineligible by the investigator's judgment

18age 0month 0week old over
No limit

Problems with low tongue pressure due to tracheal tube

To statistically compare the changes in tongue pressure between the intervention and non-intervention groups following a tongue exercise program in patients who had a tracheal tube inserted for more than 48 hours after cardiovascular surgery (valve surgery and coronary artery bypass graft surgery).
Statistical comparison of tongue pressure changes between the intervention and non-intervention groups following a tongue exercise program using a pressure training tool.

Tongue pressure measurement test to determine the effect of tongue exercise training (3-week program) on the intervention group and non-intervention group.
(The patient should always be in a sitting position, sitting on the bed, or sitting on the edge of the bed during the measurement. If the patient has dentures, the dentures will be removed from the first measurement, and since the patient has no front teeth, the blowtorch will be fixed with the gums and gauze will be applied to protect the gums). The following data were collected and compared for the percentage of patients with a tongue pressure of 20 kPa or higher on days 2 to 5 after tracheal tube removal (after withdrawal when NPPV is worn) to day 21, and for the percentage of patients with a tongue pressure of 20 kPa or higher on day 21.
Pa on days 2-5 of tracheal tube removal (after withdrawal in the case of NPPV placement) to 21 days.

(1) Subject assessment (intervention, non-intervention): history of medical history (comorbidities), surgical history, presence of allergies, age, sex ratio, weight, BMI, SG evaluation, RSST, MWST, VF, VE, ADL, eating pattern, duration of preoperative swallowing grade increase
(2) Length of time on ventilator, length of time before oral diet initiation, length of stay in ICU/CCU, and length of hospital stay for the subject patient

Showa University Koto Toyosu Hospital
Research fee within the faculty of Showa University
Not applicable
Ethics Committee on Research Involving Human Subjects at Showa University
1-5-8 Hatanodai Sinagawaku Tokyouto, Tokyo

+81-3-3784-8129

m-rinri@ofc.showa-u.ac.jp

No

none

History of Changes

No Publication date
3 July. 20, 2023 (this page) Changes
2 July. 01, 2023 Detail Changes
1 June. 13, 2023 Detail