Protocol summary

Summary
This is a randomized controlled trial study that was conducted to evaluate the effect of clinical audit process on the level of tracheostomy and endotracheal tube suctioning skill in nurses and anesthesia technicians working in intensive care units in 2013-14. Research setting was AJA hospitals in Tehran, Iran that had intensive care units and were randomly allocated in two groups of intervention (3 hospitals) and control (3 hospitals). All of nurses and anesthesia technicians working in intensive care units (70 in the intervention group and 65 in the control group) recruited by census method. Inclusion criteria included anesthesia technicians and nursing staff in the intensive care units with an associate degree or higher and at least two months work experience in the intensive care units. Exclusion criteria were unwillingness to maintain in the study and having very good score in the pre-intervention phase. The intervention was conducted via implementation of the five-stage clinical audit in the intervention group. For detection of endotracheal and tracheostomy tube suctioning skill in subjects, pre- and post intervention, the checklist was used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080123446N1
Registration date: 2015-10-05, 1394/07/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-05, 1394/07/13
Registrant information
Name
Fatemeh Teymouri
Name of organization / entity
AJA University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5588 0283
Email address
z.farsi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
This research was funded by a grant from Vice chancellor for research of AJA University of Medical Sciences.
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of clinical audit process on the endo-tracheal and tracheostomy suctioning skills of nurses working in the critical care units )ICU) in AJA hospitals in Tehran
Public title
The effect of clinical audit process on the suctioning skills of nurses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: anesthesia technicians and nursing staff in the ICUs with an associate degree or higher; at least two months work experience in the ICUs. Exclusion criteria: unwillingness to maintain in the study; having very good score in the pre-intervention phase.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 135
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
The Research Council and the Research Ethics committee in the AJA University of Medical Sciences
Street address
AJA University of Medical Sciences,Etemadzadeh St., Fatemi St., Tehran, Iran.
City
Tehran
Postal code
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
9214

Health conditions studied

1

Description of health condition studied
Tracheostomy
ICD-10 code
Z43.0
ICD-10 code description
Attention to tracheostomy

Primary outcomes

1

Description
Endotracheal and tracheostomy Suctioning Skill
Timepoint
pre intervention and one month after intervention
Method of measurement
checklist

Secondary outcomes

empty

Intervention groups

1

Description
Five-stage of clinical audit including assessment of suction procedure skill,comparison of current situation with standards, identifying weaknesses, face to face education in 45 min, and reassessment of suction procedure skill.
Category
Other

2

Description
Control group: Assessment of suction procedure skill,comparison of current situation with standards, identifying weaknesses, and reassessment of suction procedure skill.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
502 hospital
Full name of responsible person
Sara Rashidifar
Street address
502 Hospital, Intersection of Taleghani and Bahar St., Taleghani St. Tehran, Iran
City
Tehran

2

Recruitment center
Name of recruitment center
Khanevadeh Hospital
Full name of responsible person
Street address
Khanevadeh Hospital, Kaj St., Sepah Padegan St., Shariati St., Tehran, Iran
City
Tehran

3

Recruitment center
Name of recruitment center
Beasat Hospital
Full name of responsible person
Street address
Beasat Hospital, Before Afsarieh, Beasat Highway, Tehran, Iran
City
Tehran

4

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Street address
Imam Reza Hospital, Etemadzadeh St., Fatemi St., Tehran, Iran
City
Tehran

5

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Street address
Golestan Hospital, before Heravi Square, Saiyad Shirazi Highway, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
AJA University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr. Kamran Azma
Street address
Vice chancellor for research, AJA University of Medical Sciences, Etemadzadeh St., Fatemi St., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
AJA University of Medical Sciences, Vice chancellor for research
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
AJA University of Medical Sciences
Full name of responsible person
Shahla Aliyari
Position
PhD/ Research Manager
Other areas of specialty/work
Street address
Faculty of Nursing, AJA University of Medical Sciences, Kaj Street, Shariati Street, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 7750 0404
Fax
Email
aliyar_shah@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Fatemeh Kalrozi
Position
MSC
Other areas of specialty/work
Street address
Faculty of Nursing, AJA University of Medical Sciences, Kaj Street, Shariati Street, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 7750 0404
Fax
Email
f.kalrozi@ajaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Maryam Nezamzadeh
Position
MSc
Other areas of specialty/work
Street address
Faculty of Nursing, AJA University of Medical Sciences, Kaj Street, Shariati Street, Tehran, Iran.
City
Tehran
Postal code
Phone
00
Fax
Email
nezamzadeh_maryam@yahoo.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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