Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002055280
Ethics application status
Approved
Date submitted
2/12/2018
Date registered
21/12/2018
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Date results information initially provided
21/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
efficacy of noble metal alloy endotracheal tube in prevention of ventilatory associated pneumonia
Scientific title
efficacy of noble metal alloy endotracheal tube in prevention of ventilatory associated pneumonia
Secondary ID [1] 296761 0
NONE
Universal Trial Number (UTN)
Trial acronym
ENEATVP
Linked study record
NONE

Health condition
Health condition(s) or problem(s) studied:
Ventilatory associate pneumonia. 310644 0
Condition category
Condition code
Infection 309358 309358 0 0
Other infectious diseases
Respiratory 309419 309419 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group received noble metal alloy coated endotracheal tube used in patients admitted in the toxicology critical care, requiring mechanical ventilation, performed either by emergency doctors and critical care doctors.
endotracheal tube is a device used to protect airway in patients unable to maintain their vital signs.
the duration of intubation depends upon the general status (evaluated by research supervision), but the outcomes were evaluates after 5 days of intervention. there is no min or max duration of time for the alloy tube to stay in place
Intervention code [1] 313071 0
Prevention
Intervention code [2] 313098 0
Treatment: Devices
Comparator / control treatment
The control group was intubated using silicon uncoated endotracheal tube..
Control group
Active

Outcomes
Primary outcome [1] 308314 0
The primary outcome was the ventilatory associated pneumonia appearance, assessed by the presence of pathogenic bacteria in the tracheal tube.
Timepoint [1] 308314 0
Assessment for ventilatory associated pneumonia was performed after 5 days of mechanical ventilation.
Primary outcome [2] 308315 0
we want to identity the spectrum of endotracheal microbiology using local cultures. this is an exploratory outcome.
Timepoint [2] 308315 0
Timepoint: after 5 days post enrollment.
Secondary outcome [1] 354601 0
secondary outcome: the presence of sepsis, using hemoculture.
Timepoint [1] 354601 0
secondary outcome was assess at 5 days after enrollment.

Eligibility
Key inclusion criteria
We included in the study all subjects that needed mechanical ventilation for acute drug poisoning.
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were: trauma patients, inter hospital transferred patients, family refusal.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The intubation was performed with numbered containers. each container had either normal endotracheal tube or noble metal alloy tube.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a
statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/01/2017
Date of last participant enrolment
Anticipated
Actual
31/12/2017
Date of last data collection
Anticipated
Actual
15/01/2018
Sample size
Target
188
Accrual to date
Final
180
Recruitment outside Australia
Country [1] 21092 0
Romania
State/province [1] 21092 0
BUCHAREST

Funding & Sponsors
Funding source category [1] 301340 0
Self funded/Unfunded
Name [1] 301340 0
not appliable
Country [1] 301340 0
Primary sponsor type
Individual
Name
tincu radu ciprian
Address
tincu radu ciprian
bucharest clinical emergency hospital
8 floreasca way, Bucharest, 014471, district 1, Romania
Country
Romania
Secondary sponsor category [1] 301006 0
None
Name [1] 301006 0
Address [1] 301006 0
Country [1] 301006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302079 0
Hospital Ethics Committee
Ethics committee address [1] 302079 0
8 Floreasca Way Bucharest
Ethics committee country [1] 302079 0
Romania
Date submitted for ethics approval [1] 302079 0
30/03/2016
Approval date [1] 302079 0
06/04/2016
Ethics approval number [1] 302079 0
8081

Summary
Brief summary
Background and Goal of study: Ventilator-associated pneumonia (VAP) is an important matter in patients careed in Intensive Care Units, having an increased burden. The noble metal alloy coated endotracheal tubes (ETTs) have been designed to prevent bacterial colonization and to reduce VAP, but their efficacy, benefits and disadvantages available data are still full of controversy. The objective was to determine whether VAP incidence can be influenced using noble metal alloy ETTs in patients admitted for acute drug poisoning requiring mechanical ventilation.
Material and Methods: A randomized conrolled study was conducted in Critical Care Toxicology Unit, in Bucharest Clinical Emergency Hospital. We enrolled all intubated patients for coma due to drug poisoning, considering the profile of the clinic. All patients were assigned to undergo either uncoated ETTs or noble metal alloy-coated ETTs. Primary outcomes were VAP appearance at 5 days and endotracheal microbiology analysis, while sepsis incidence was secondary outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89054 0
Dr tincu radu ciprian
Address 89054 0
8 floreasca way, Bucharest, District 1, Romania
principal investigator; Radu Ciprian Tincu,
Bucharest Clinical Emergency Hospital
Country 89054 0
Romania
Phone 89054 0
0040722639789
Fax 89054 0
Email 89054 0
[email protected]
Contact person for public queries
Name 89055 0
Dr tincu radu ciprian
Address 89055 0
name of the contact person’s work organisation; tincu radu ciprian
8 floreasca way, Bucharest, District 1, Romania
Country 89055 0
Romania
Phone 89055 0
0040722639789
Fax 89055 0
Email 89055 0
[email protected]
Contact person for scientific queries
Name 89056 0
Dr tincu radu ciprian
Address 89056 0
8 floreasca way, Bucharest, District 1, Romania
name of the contact person’s work organisation; Radu Ciprian Tincu,
Country 89056 0
Romania
Phone 89056 0
0040722639789
Fax 89056 0
Email 89056 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after deidentification
When will data be available (start and end dates)?
from 15th of January 2019 until 15th April 2019
Available to whom?
Data will be available for researchers in the same area of interest.
Available for what types of analyses?
IPD metaanalyses
How or where can data be obtained?
access subject to approvals by Principal Investigator requirement to sign data access agreement,


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of Noble Metal-alloy Endotracheal Tubes in Ventilator-associated Pneumonia Prevention: a Randomized Clinical Trial.2022https://dx.doi.org/10.4274/balkanmedj.galenos.2021.2021-7-86
N.B. These documents automatically identified may not have been verified by the study sponsor.