Protocol summary

Summary
Objective:effect of an upper respiratory care program on incidence of ventilator-associated pneumonia in mechanically ventilated patient in Al-Zahra hospital intensive care units,Isfahan University of Medical Sciences, 2014. Study Design: randomized clinical trial. Study population: patients admitted to intensive care units of Esfahan Al-Zahra hospital. Inclusion criteria: willingness to participate in the study: Patients above 18,mechanical ventilation for more than 24 hr,free of pneumonia or respiratory infections by the time of arrival to the hospital,free of pneumonia before intubation,free of pneumonia in the first 48 hr of intubation, free of limitations due to head elevation.In intervention group the patients were taken under an upper respiratory care program including oral and subglottic secretion suction before every position change, head elevation during the treatment and measuring and controlling the trachea cuff pressure twice a day, in the control group the upper respiratory care program is carried out as the routine protoco.interference:during the first 5 days of intubation the upper respiratory care program was applied to the interference group. evaluation of ventilator related pneumonia variables carried out in control and intervention group during the 5 days.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013122215898N1
Registration date: 2014-05-10, 1393/02/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-05-10, 1393/02/20
Registrant information
Name
Nasim Bahrami
Name of organization / entity
Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 1624 7527
Email address
bahrami_n@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an upper respiratory care program on incidence of ventilator-associated pneumonia in mechanically ventilated patient in Al-Zahra hospital intensive care units,Isfahan University of Medical Sciences.
Public title
The effect of an upper respiratory care program on incidence of ventilator-associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Patients above 18,mechanical ventilation more than 24 hr,free of pneumonia or hospital infections before and in the first 48 hr of intubation, free of invasive antibiotics, free of limitations due to head position of medical bed, Exclusion Criteria: Death before the end of the study, extubation before the end of the study,Transfer to other wards or hospitals before the end of the study, undergoing surgery during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee of Isfahan university of medical science.
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib,Isfahan Isfahan Isfahan Iran, Islamic Republic Of 461-81746
City
Isfahan
Postal code
Approval date
2014-05-05, 1393/02/15
Ethics committee reference number
391295

Health conditions studied

1

Description of health condition studied
Ventilator Associated Pneumonia
ICD-10 code
J95.9
ICD-10 code description
Postprocedural respiratory disorder, unspecified

Primary outcomes

1

Description
Incidence of Ventilator Associated Pneumonia
Timepoint
Before intervention, day 3, day 4, day 5,
Method of measurement
Clinical Pulmonary Infection Score, CPIS.

Secondary outcomes

empty

Intervention groups

1

Description
In the Intervention group, the upper respiratory care program was carried out, which included oral and subglottic secretion suction with 100-140 mmHg before each change position, head elevation every 12 hours (8am-8pm) using Oblique resulting the patient being fixed in 45◦,measuring the trachea cuff pressure twice a day every 12 hours (8 am-8pm) resulting in the fixed interval of 20-30 mmH2O.
Category
Prevention

2

Description
In control group patients were taken under routine upper respiratory care, including oral and subglottic secretion suction every two hours for patients under mechanical ventilation independent of the position change routines. Measuring and controlling the trachea cuff pressure were not carried under any special protocols depending on the environmental characteristics. head elevation was taken under consideration but not documented.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
nasim bahrami
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Peiman Adibi
Street address
Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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
Isfahan University of Medical Science
Full name of responsible person
nasim bahrami
Position
MSc student in critical care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2941
Fax
Email
bahrami_n@nm.mui.ac.ir,n_bahrami2000@yahoo.com,nasim.bahrami58@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
soheila bakhtiari
Position
MSc in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2911
Fax
Email
bakhtiari@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
nasim bahrami
Position
MSc student in critical care nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
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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