To specify the effect of air cushion to prevent occipital pressure ulcer in children under heart surgery
Design
This investigation is done randomly with 126 specimens in control and intrusive group by clinical trial with 2 parallel groups
Settings and conduct
This investigation would be clinical trial that would be done on 126 sick children under open heart surgery referring to Shahid Madani Tabriz and Rajae heart center that have not long hospitalization history in intensive care unit of children. After getting permission from moral committee of medical university of Iran and providing them for medical university of Tabriz and consequently will be given to Shahid Madani and Shahid Rajae heart center, the researcher will start the experimental process.Therefore, the researcher in heart surgery unit, would select children from 0 to 12 years who are candidates of surgery with random and sequence and with getting permission from their parents, will collect data. In addition, the condition of occipital region of their head are observed and will be scored by the Browden checklist.
Participants/Inclusion and exclusion criteria
Children who are 0 to 12 candidates for heart surgery.
Those children that go under open heart surgery and this happens via heart and lung pump.
conditions of not being accounted:
children who are attached to ventilator before heart surgery
patients who pass away during the surgery
patients who pass away in intensive care unit
children whose heart surgery is canceled after anesthesia for any reason
Intervention groups
Intrusive groups: Those groups that by usin air cushion prevent occipital pressure ulcer in children
control group: Those groups who used conventional method for under head of children
Main outcome variables
Preventing occipital pressure ulcer
reduction in duration of hospitalization
reduction in costs of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190630044056N1
Registration date:2019-08-07, 1398/05/16
Registration timing:registered_while_recruiting
Last update:2019-08-07, 1398/05/16
Update count:0
Registration date
2019-08-07, 1398/05/16
Registrant information
Name
Azita Matinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 0548
Email address
matinpour.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-07, 1398/04/16
Expected recruitment end date
2019-08-31, 1398/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on effect of using air cushion on preventing occipital pressure ulcer of children under heart surgery
Public title
Investigation on effect of air cushion on preventing occipital pressure ulcer of children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children 0 to 12 candidates for heart surgery.
Those Children that go under open heart surgery and this happens via heart and lung pump.
Children who diagnosis of their heart illness is confirmed by surgeon and is in queue for heart surgery.
Exclusion criteria:
Children who are attached to ventilator before heart surgery.
Patients who pass away during the surgery.
Patients who pass away in intensive care unit.
Children whose heart surgery is canceled after anesthesia for any reason.
Children whose open heart surgery is changed to close one.
Age
From 1 day old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
More than 1 sample in each individual
Number of samples in each individual:
63
The number of specimens equals to 58 persons and with the possibility of 10% reduction in number of final specimens, are determined 63 persons. The method for calculating number of specimens: for determining number of specimens in meaningful level of 0.05 and power of examination of 80% with considering the 30% pressure ulcer and with the hypothesis that occipital pressure ulcer in children under heart surgery in intrusive group comparing to control group reduces by 20% in order to be considered meaningful in statistical overview.
Randomization (investigator's opinion)
Randomized
Randomization description
The selected qualified specimens, in order to be studied randomly, by using the www.Random.org website and by categorizing with 4 and 6 blocks to 2 groups will be specified.In order to conceal specification, after random sequence by number of specimens, several aluminium envelopes are prepared and cards are placed in envelops sequential. To preserve random sequence, the envelopes are numbered in order. Finally, the sealed envelope are placed in order into a box. By the time of the registration of the participants, by the considering the the sequence of qualified participants, they opt for a card and the specified group of this participant will be appeared.
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
Ethics committee of Iran University of Medical Science
Street address
Iran University of Medical Science, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
88671613
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.373
Health conditions studied
1
Description of health condition studied
Occipital pressure ulcer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Occipital pressure ulcer incidence
Timepoint
Investigation on incidence of occipital pressure ulcer after surgery up to 3 days in children ICU
Method of measurement
Index of pressure ulcer
2
Description
Prediction of pressure ulcer score
Timepoint
After surgery in operation room and in children ICU
Method of measurement
Prediction of bradan and bradan q pressure ulcer measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intrusive group: Using air cushion in children under heart surgery in heart operation room and 3 days after heart surgery in children ICU
Category
Prevention
2
Description
Control group: using routine position as cloth rolls or jelly occipital position in children under heart surgery and 3 days after surgery in children ICU
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajae hospital
Full name of responsible person
Azita Matinpour
Street address
No.38, 8 metri 26 Ave., Velayat blvd., sahand Alley, Elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
5168619596
Phone
+98 41 3382 0548
Email
matinpour.a@tak.iums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Madani hospital
Full name of responsible person
Azita Matinpour
Street address
No. 38, 8 metri 26 Ave., velayat Blvd., Sahand Valley, Elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
5168619596
Phone
+98 41 3382 0548
Email
matinpour.a@tak.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Shahid hemmat highway, next to Milad Tower, Iran university
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1111
Email
kmalakouti@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azita Matinpour
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.38, 8 metri 26 Ave., velayat Blvd., Sahand Valley, Elgoli
City
Tabriz
Province
East Azarbaijan
Postal code
5168619596
Phone
+98 41 3382 0548
Email
matinpour.a@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sedeghe Khanjari.
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursery department, Valiasr street, Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8867 1613
Email
khanjari.s@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azita Matinpour
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
38 No. 8 metri 25 Ave., Velayat Ave., Sahand valley, Elgoli
City
Tehran
Province
East Azarbaijan
Postal code
5168619596
Phone
+98 41 3382 0548
Email
matinpour.a@tak.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available