UMIN-CTR Clinical Trial

Public title

Measurement of normal pharyngeal pressure with High Resolution Manometry System which has 20 circumfeferential pressure sensors.

Acronym

Measurement of normal pharyngeal pressure with High Resolution Manometry System.

Scientific Title

Measurement of normal pharyngeal pressure with High Resolution Manometry System which has 20 circumfeferential pressure sensors.

Scientific Title:Acronym

Measurement of normal pharyngeal pressure with High Resolution Manometry System.

Region

Japan

Condition

Dysphagia

Classification by specialty

Oto-rhino-laryngology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To find the numerical value of the healthy person's swallow pressure when using Starlet manometry system, High Resolution Manometry with 20 circumferential sensors, and estimate the difference by the swallow amount, and gender difference.
When deglutition pressure is measured by Manometry, a definitive measurement is calculated by averaging several measurements. We inspect the number of the measurement required to establish reliable deglutition pressures in normal subjects.

Basic objectives2

Others

Basic objectives -Others

The difference between healthy person's swallow movement corrugation and swallow motion corrugation of a swallow obstacle patient by using Starlet manometry system.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

UES relaxation time.
The item mentioned above is evaluated at catheterization.

Key secondary outcomes

The maximum pressure in the velopharynx and maximum pressure in the meso-hypopharynx were measured during swallowing.
The maximum pressure in the UES at the start of the swallowing motion.
The minimum pressure after the swallowing motion.
The maximum UES pressure after the pressure waveforms in the velopharynx and meso-hypopharynx disappeared.
The durations of pressure above baseline in the velopharynx and meso-hypopharynx regions.
The time from the point at which the UES pressure started to increase until it reached the maximum pressure at the start of the swallowing motion.
The time from when the UES pressure reached the maximum pressure until completion of the gradual decrease, after the waveforms in the velopharynx and meso-hypopharynx disappeared.

Change of the measurement values above-mentioned by the amount of volus.

The number of the measurement to establish reliable deglutition pressures.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

50 Healthy persons
10 times saliva swallowing, 10times of swallowing water 3ml, 10times of swallowing water 5ml, and 10times of swallowing water 10ml.

Swallowing of each of which is a continuous enforcement.

For one of the healthy subjects, the use of the testing equipment to only once as a general rule, and measurement to another day is not performed.

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

20

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

Healthy adults

Key exclusion criteria

Person with dysphagia
Person with foreign body sensation in the throat
Person who can not be subject to inspection of using manometry because of gag reflex
Person with some sort of ill-health(For example, the common cold, hangover)

Target sample size

50

Name of lead principal investigator

1st name	Matsusato
Middle name
Last name	Tsuyumu

Organization

The Jikei University School of Medicine

Division name

Department of Otorhinolaryngology

Zip code

105-8471

Address

3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan

TEL

03-3433-1111

Email

tsuyumu@jikei.ac.jp

Name of contact person

1st name	Matsusato
Middle name
Last name	Tsuyumu

Organization

The Jikei University School of Medicine

Division name

Department of Otorhinolaryngology

Zip code

105-8471

Address

3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan

TEL

03-3433-1111

Homepage URL

Email

tsuyumu@jikei.ac.jp

Institute

Department of Otorhinolaryngology, The Jikei University School of Medicine

Institute

Department

Personal name

Organization

The Jikei University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Jikei University School of Medicine

Address

3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan

Tel

03-3433-1111

Email

h-rinken@jikei.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

Date of disclosure of the study information

2014

Year

04

Month

16

Day

URL releasing protocol

https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0040-1702966

Publication of results

Partially published

URL related to results and publications

https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0040-1702966

Number of participants that the trial has enrolled

40

Results

There was a tendency for the UES relaxation time to increase with swallowing volume. The dry swallow induced a significantly lower maximum UES pressure just after swallowing than did the 3-, 5-, and 10-ml swallows. The UES relaxation time was significantly prolonged with an increase in the bolus volume.
It was clarified that the number of times required for measurement was 7 times for the value of UES pressure increase before swallowing, 3 times for UES opening time, and 6 times for other measured values.

Results date posted

2019

Year

08

Month

18

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Healthy person
People who have no symptoms in the pharynx and larynx
No abnormal findings in the pharynx or larynx on endoscopy

Patients with dysphagia

Participant flow

Those who know the research by word of mouth will participate in the research by themselves.

Adverse events

none

Outcome measures

Maximum velopharyngeal pressure
Maximum oropharyngeal pressure
Pre-swallow UES pressure
Post swallow UES pressure
Velopharyngeal Duration
Oropharyngeal duration
UES opening time

The average value above and the number of measurements required estimated from it

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2014

Year

01

Month

01

Day

Date of IRB

2013

Year

11

Month

11

Day

Anticipated trial start date

2014

Year

04

Month

16

Day

Last follow-up date

2026

Year

11

Month

10

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We examined the data for dysphagia patients were examined using this Manometry.Although there are different types of dysphagia,Dysphagia patients was confirmed to tend to UES pressure during UES dilatation is not sufficiently reduced.
In addition, it was clarified that the number of times required for measurement was 7 times for the value of UES pressure increase before swallowing, 3 times for UES opening time, and 6 times for other measured values.

We are considering continuing further research.

Registered date

2014

Year

04

Month

16

Day

Last modified on

2025

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015967