This study is a randomized and single blind study which aims to examine the effect of educational program on nurses' knowledge and practice in management of tracheal tube cuff in intensive care unit patients. Subjects will be selected from four hospitals in Tehran, Iran including Imam Khomeini, Sina, Dr, Shariati and Rasool Akram. Subjects are intubated patients and nurses form intensive care units. Inclusion criterion for nurses is work experience in intensive care units at least for one-year. In addition, inclusion criteria for patients are age over 18-year old; having endotracheal tube for more than 48 hours; having no injuries or damage in face and neck; having no tumors in the respiratory tract and stable hemodynamic conditions. The intervention is an educational program about endotracheal cuff management. The content will provide to subjects in lecture and written material. Nurses' knowledge and practice will be measured two weeks before and after education through self-designed questionnaire and check list. It is expected that educational program will increase awareness and improve performance and reduce complications of endotracheal tube cuff may lead nurses.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112615560N1
Registration date:2013-12-25, 1392/10/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-25, 1392/10/04
Registrant information
Name
rogheah javadi Ali Gheshlaghi
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
javadi_r@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing Faculty of Tehran University of Medical Sciences
Expected recruitment start date
2013-12-07, 1392/09/16
Expected recruitment end date
2014-01-06, 1392/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the education program on nurses´ knowledge and performance in the endotracheal tube cuff management
Public title
Effect of education in endotracheal tube cuff management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion for nurses: working experience in intensive care units at least for one-year. Inclusion criteria for patients are age over 18-year old; having endotracheal tube for more than 48 hours; having no injuries or damage in face and neck; having no tumors in the respiratory tract and stable hemodynamic conditions. Exclusion criterias for nurses are leave a job or retirement along sampling (before and after intervention), and for patients are death or weaning from endotracheal tube.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran University of Medical Sciences
Street address
tehran medisine university- poor sina Ave- keshavarz Bolvd- tehran-Iran
City
tehran
Postal code
Approval date
2013-08-07, 1392/05/16
Ethics committee reference number
827
Health conditions studied
1
Description of health condition studied
Tracheal tube cuff
ICD-10 code
Y70
ICD-10 code description
Anaesthesiology devices associated with adverse incidents
Primary outcomes
1
Description
Awareness
Timepoint
2 weeks before and after intervention
Method of measurement
Self-designed awareness questionner
2
Description
Performance
Timepoint
2 weeks before and after intervention
Method of measurement
Self reporting/ self-designed performance check list
Secondary outcomes
1
Description
Tracheal tube cuff management
Timepoint
2 weeks before and after intervention
Method of measurement
Check list
Intervention groups
1
Description
Education of Intervention groups; at beginning mass education and then person to person training at the patient's bedside by lecture, questions and answers method with usage of pamphlet for 3 days.
Category
Other
2
Description
in control groups no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Street address
City
Tehran
4
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Research Deputy department- 16 Azar ave- keshavarz bolvard- tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Javadi Ali Gheshlaghi Rogheah
Position
MSc student
Other areas of specialty/work
Street address
No 18- 5 roose- Kaj Ave- Amir Kabir street- Tehran
City
Tehran
Postal code
Phone
+98 21 4473 3392
Fax
Email
javadirogheah@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadi Noraldin
Position
PhD
Other areas of specialty/work
Street address
Tohid sq- Nursing facuality
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
mohammadi_no@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rogheah Javadi Ali Gheshlaghi
Position
MSc student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences- Poor Sina ave- Keshavarz Bolvard- Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
+98 21 4473 3392
Email
rogheahjavadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)