UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002364
Receipt No. R000002901
Scientific Title Effects of heated humidifier setting on oral dryness during noninvasive positive pressure ventilation.
Date of disclosure of the study information 2009/08/31
Last modified on 2011/01/17

* 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 Effects of heated humidifier setting on oral dryness during noninvasive positive pressure ventilation.
Acronym Heated humidifier setting and oral dryness during noninvasive positive pressure ventilation.
Scientific Title Effects of heated humidifier setting on oral dryness during noninvasive positive pressure ventilation.
Scientific Title:Acronym Heated humidifier setting and oral dryness during noninvasive positive pressure ventilation.
Region
Japan

Condition
Condition Patients with noninvesive positive pressure ventilation.
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate oral dryness and discomfort during NIV at differential setting of heated fumidifier.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral dryness and discomfort
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Maximum heated humidifier setting
Interventions/Control_2 Medium heated humidifier setting
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 Patient who suffered from acute respiratory failure, and were expected to receive noninvesive positive pressure ventilation for at least 24 h.
Key exclusion criteria Patients who are psychiatric illness or suspected encephalopathy (drug overdose, hepatic failure) leading to difficulty in scoring their discomfort and severe respiratory or hemodynamic instability which could not allow patients take off NIV mask for evaluating oral dryness.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Oto
Organization Tokushima University Hospital
Division name Emergency and Critical Care Medicine
Zip code
Address 3-18-15 Kuramoto-cho Tokushima city Tokushima Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jun Oto
Organization Tokushima University Hospital
Division name mergency and Critical Care Medicine
Zip code
Address
TEL
Homepage URL
Email joto@clin.med.tokushima-u.ac.jp

Sponsor
Institute Emergency and Critical Care Medicine Tokushima University Hospital
Institute
Department

Funding Source
Organization Emergency and Critical Care Medicine Tokushima University Hospital
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
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
2009 Year 08 Month 31 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
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
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 01 Month 01 Day
Date analysis concluded
2011 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 21 Day
Last modified on
2011 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002901

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.