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 UMIN000003371
Receipt No. 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

* 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 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&reg)
Interventions/Control_2 The use of the tracheal tube with subgosttic secretion drainage(Type2:Taper Guard Evac&reg)


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
Email

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
Email nobu99@nms.ac.jp

Sponsor
Institute Chiba hokuso hospital,Nippon medical school
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004097

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.