Protocol summary

Summary
The purpose of this study is to determine the effect of brushing with pure water on the incidence of ventilator-associated pneumonia in hospitalized patients in intensive care units. Study population, patients in intensive care units in selected hospitals in Yazd is 1393. This study is randomized clinical trial with a sample size of 168 patients is determined by sampling (random allocation) will be. The inclusion criteria for this study included an endotracheal tube, having teeth, aged between 20 to 85 years, lack of aspiration, lack of symptoms, the disease is immunosuppressive. The control group consisted of 84 patients with common hospital procedures, including control of tracheal tube cuff, rinsing with saline and suction mouth - throat is to get. The intervention group consisted of 84 patients who received the hospital routine brushing with distilled water to get. VAP diagnosis based on criteria CIPS (CLINICALLY INFECTION PULMONARY SCORE) is. The outcomes of patients with ventilator associated pneumonia are

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102115101N1
Registration date: 2014-05-08, 1393/02/18
Registration timing: na

Last update:
Update count: 0
Registration date
2014-05-08, 1393/02/18
Registrant information
Name
Fakhri Torki
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
f.torki114@ssu.ac.ir
Recruitment status
Not enough for processing
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-09-01, 1393/06/10
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effect of brushing with pure water on the incidence of ventilator-associated pneumonia in patients in intensive care units
Public title
Investigate the effect of brushing with pure water on the incidence of ventilator-associated pneumonia in patients in intensive care units
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria for this study: a tracheal tube; having teeth; aged between 20-85 years Exclusion criteria: signs of aspiration; debilitating disease of the immune system
Age
From 20 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 168
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Central Buillding of University ,Bahonar Square
City
Yazd
Postal code
Approval date
2014-02-03, 1392/11/14
Ethics committee reference number
17/1/223783

Health conditions studied

1

Description of health condition studied
Ventilator Associated Pneumonia
ICD-10 code
J95.8
ICD-10 code description
Other postprocedural respiratory disorders

Primary outcomes

1

Description
Ventilator Associated Pneumonia
Timepoint
During the stay in the intensive care unit
Method of measurement
Turbidity and the development of radiographic infiltrate plus two other symptoms include a high temperature of 38.5 or below 36.5 ° C, leukocytosis or leukopenia (above 10,000 or below 1500), purulent secretions, endotracheal tube and positive culture of tracheal aspirates

Secondary outcomes

empty

Intervention groups

1

Description
Control group: routine hospital procedures, including control of tracheal tube cuff, rinsing with saline and suction mouth - pharynx is receiving
Category
Prevention

2

Description
Intervention group: in addition to receiving routine hospital procedures, including control of tracheal tube cuff, rinsing with saline and suction mouth - throat, brushing with pure water to get
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Fakhri Torki
Street address
Shohadaye Sofee Street, Darvazeh Shiraz Square, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Fatemah Ezoddini
Street address
Deputy for research, Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fakhri Torki
Position
Anesthesiology
Other areas of specialty/work
Street address
School of Nursing Midwifery,Buali street, Safaieh
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
F.torki114@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
Nursing PHD
Other areas of specialty/work
Street address
School of Nursing Midwifery,Buali street, Safaieh
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
Nasiriani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Fakhri Torki
Position
Anesthesiology
Other areas of specialty/work
Street address
School of Nursing Midwifery,Buali street, Safaieh
City
Yazd
Postal code
Phone
Fax
Email
F.torki114@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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