UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003371 |
|---|---|
| Receipt number | R000004097 |
| Scientific Title | A randomized clinical trial of the tracheal tube with subglottic secretion drainage for preventing ventilator-associated pneumonia (VAP). |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2012/04/01 01:16:35 |
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Basic information
Public title
A randomized clinical trial of the tracheal tube with subglottic secretion drainage for preventing ventilator-associated pneumonia (VAP).
Acronym
Comparison between VAP incidence by the two types of tracheal tube with subglottic secretion drainage.
Scientific Title
A randomized clinical trial of the tracheal tube with subglottic secretion drainage for preventing ventilator-associated pneumonia (VAP).
Scientific Title:Acronym
Comparison between VAP incidence by the two types of tracheal tube with subglottic secretion drainage.
Region
| Japan |
Condition
Condition
ventilator-associated pneumonia (VAP)
Classification by specialty
| Pneumology | Infectious disease | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aim is to investigate the difference of the VAP incidence by two types of tracheal tubes with subglottic secretion drainage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
VAP incidence
Episodes of VAP/1000 ventilator days
Key secondary outcomes
Twenty eight days mortality, Hospital mortality, Duration of mechanical ventilation, Length of ICU stay, Length of hospital stay, The days from an entry to the VAP onset, Cost effectiveness.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The use of the tracheal tube with subgosttic secretion drainage
(Type1:Hi-Lo Evac®)
Interventions/Control_2
The use of the tracheal tube with subgosttic secretion drainage(Type2:Taper Guard Evac®)
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
The patients who are intubated and expected to receive mechanical ventilation at least 72 hours in the ICU.
Key exclusion criteria
1) Patients who are transferred from another hospital and received mechanical ventilation.
2) Patients who received tracheostomy within 72 hours from admission.
3) Patients that it was judged that nasal intubation was necessary
4) Patients who are less than 18 years old.
5) Patients who judged that a medical attendant was inappropriate.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Saito |
Organization
Chiba hokuso hospital,Nippon medical school
Division name
Department of emergency and critical care medicine
Zip code
Address
1715,kamagari,inba-mura,inba-gun,chiba
TEL
0476-99-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba hokuso hospital,Nippon medical school
Division name
Department of emergency and critical care medicine
Zip code
Address
TEL
Homepage URL
nobu99@nms.ac.jp
Sponsor or person
Institute
Chiba hokuso hospital,Nippon medical school
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2010 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 24 | Day |
Last modified on
| 2012 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004097
