UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014456
Receipt number R000016812
Scientific Title Humidification performance of humidifying devices for tracheotomized patients with spontaneous breathing.
Date of disclosure of the study information 2014/09/01
Last modified on 2018/11/14 11:19:04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Humidification performance of humidifying devices for tracheotomized patients with spontaneous breathing.

Acronym

Humidifying devices for tracheotomized patients.

Scientific Title

Humidification performance of humidifying devices for tracheotomized patients with spontaneous breathing.

Scientific Title:Acronym

Humidifying devices for tracheotomized patients.

Region

Japan


Condition

Condition

Tracheotomized patients

Classification by specialty

Intensive care medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate humidifying performance of heat and humidity exchanger for tracheotomized patients and high flow tracheotomy interface in clinical settings.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

temperature and humidity of expired gas

Key secondary outcomes



Base

Study type


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

heat and moist exchanger for tracheotomized patients

Interventions/Control_2

high flow tracheotomy interface

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Tracheotomized patients who are admitted in intensive care unit.

Key exclusion criteria

trachal bleeding
shock

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Oto

Organization

The University of Tokushima Graduate School

Division name

Emergency and Critical Care Medicine

Zip code


Address

3-18-15 Kuramotocho Tokushima-city Tokushima Japan

TEL

088-633-9347

Email

joto@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jun Oto

Organization

The University of Tokushima Graduate School

Division name

Emergency and Critical Care Medicine

Zip code


Address

3-18-15 Kuramotocho Tokushima-city Tokushima Japan

TEL

088-633-9347

Homepage URL


Email

joto@tokushima-u.ac.jp


Sponsor or person

Institute

The University of Tokushima Graduate School

Institute

Department

Personal name



Funding Source

Organization

The University of Tokushima Graduate School

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

The temperature with the HME was 29.9 degree and, during heated-and-humidified high-flow use was 35.3 degree (P < .001). With both the HME and the heated-and-humidified high-flow system, the relative humidity reached 100%; the absolute humidity with HME was 30.2 mg/L, and, with the heated-and-humidified high-flow system, was 40.3 mg/L (P < .001).

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

Completed

Date of protocol fixation

2014 Year 06 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 07 Month 02 Day

Last modified on

2018 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016812


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name