UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002364 |
|---|---|
| Receipt number | 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 10:44:39 |
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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
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
joto@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Emergency and Critical Care Medicine Tokushima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002901
