Back to resultsThe Effect of Care Bundle in Preventing Pressure Ulcers Caused by Medical Devices in the Pediatric Intensive Care Unit
Primary Purpose
Pressure Ulcer, Nursing Caries, Device Induced Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
care bundle application
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcer focused on measuring medical devices, pressure ulcers, Care Bundles
Eligibility Criteria
Inclusion Criteria:
- being in the pediatric intensive care unit.
- nasogastric tube, intubation tube and saturation probe attached.
- Voluntary consent of family to participate in the study
Exclusion Criteria:
- Patients with skin disease
- Patients staying less than 14 days
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
the group to which the care bundle will be applied
group not to be interfered with
Arm Description
Patients with a score of 13 or higher on the Braden QD medical instrument risk assessment scale. Patients with attached nasogastric tube, intubation tube and saturation probe.
Patients with attached nasogastric tube, intubation tube and saturation probe.
Outcomes
Primary Outcome Measures
Pressure ulcer
Medical devices related pressure ulcer
Secondary Outcome Measures
medical device induced pressure ulcer
The rate of pressure ulcers caused by medical devices in the care package group will be compared with the rates of pressure ulcers caused by medical devices in patients receiving normal care.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05406986
Brief Title
The Effect of Care Bundle in Preventing Pressure Ulcers Caused by Medical Devices in the Pediatric Intensive Care Unit
Official Title
The Effect of Care Bundle in Preventing Pressure Ulcers Caused by Medical Devices in the Pediatric Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2022 (Anticipated)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
October 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kilis 7 Aralik University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
With the development of technology in medicine, more medical instruments are used in the treatment of diseases. Although the use of these instruments provides great benefits for the patients, it can also cause some complications.One of the most important of these complications is pressure ulcer.Some care and evaluation are needed to prevent these complications.This study aims to prevent pressure ulcers with a care package for patients with high risk scores.
Detailed Description
A care package will be created with the Delphi method to prevent pressure ulcers caused by medical devices.Experimental and control groups will be formed by randomized control method.The care package created for 14 days will be applied to the experimental group. standard care will be applied to the control group.As a result, the rates of medical device-induced pressure ulcers in both groups will be compared.Children between the ages of 1 and 10 years and treated in the pediatric intensive care unit will be included in the study.Patients with any skin-related disease will not be included in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Nursing Caries, Device Induced Injury
Keywords
medical devices, pressure ulcers, Care Bundles
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental and control groups will be selected using the randomized control method.
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the group to which the care bundle will be applied
Arm Type
Experimental
Arm Description
Patients with a score of 13 or higher on the Braden QD medical instrument risk assessment scale.
Patients with attached nasogastric tube, intubation tube and saturation probe.
Arm Title
group not to be interfered with
Arm Type
No Intervention
Arm Description
Patients with attached nasogastric tube, intubation tube and saturation probe.
Intervention Type
Other
Intervention Name(s)
care bundle application
Intervention Description
The patients in the experimental group will be given care according to the current care bundle for 14 days
Primary Outcome Measure Information:
Title
Pressure ulcer
Description
Medical devices related pressure ulcer
Time Frame
14 day
Secondary Outcome Measure Information:
Title
medical device induced pressure ulcer
Description
The rate of pressure ulcers caused by medical devices in the care package group will be compared with the rates of pressure ulcers caused by medical devices in patients receiving normal care.
Time Frame
14 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
being in the pediatric intensive care unit.
nasogastric tube, intubation tube and saturation probe attached.
Voluntary consent of family to participate in the study
Exclusion Criteria:
Patients with skin disease
Patients staying less than 14 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erhan Elmaoğlu
Phone
+903488142666
Email
erhan.elmaoglu@kilis.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zerrin Çiğdem
Organizational Affiliation
Hasan Kalyoncu Univesity
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data collected by the researcher will be shared with other participants. however, information about the patient will not be shared.
Citations:
PubMed Identifier
18286861
Citation
Butler CT. Pediatric skin care: guidelines for assessment, prevention, and treatment. Dermatol Nurs. 2007 Oct;19(5):471-2, 477-82, 485.
Results Reference
result
PubMed Identifier
29246340
Citation
Curley MAQ, Hasbani NR, Quigley SM, Stellar JJ, Pasek TA, Shelley SS, Kulik LA, Chamblee TB, Dilloway MA, Caillouette CN, McCabe MA, Wypij D. Predicting Pressure Injury Risk in Pediatric Patients: The Braden QD Scale. J Pediatr. 2018 Jan;192:189-195.e2. doi: 10.1016/j.jpeds.2017.09.045.
Results Reference
result
PubMed Identifier
28387749
Citation
Freundlich K. Pressure Injuries in Medically Complex Children: A Review. Children (Basel). 2017 Apr 7;4(4):25. doi: 10.3390/children4040025.
Results Reference
result
PubMed Identifier
32904968
Citation
Puspitasari JD, Nurhaeni N, Waluyanti FT. Testing of Braden QD Scale for predicting pressure ulcer risk in the Pediatric Intensive Care Unit. Pediatr Rep. 2020 Jun 25;12(Suppl 1):8694. doi: 10.4081/pr.2020.8694. eCollection 2020 Jun 25.
Results Reference
result
PubMed Identifier
29120893
Citation
Delmore BA, Ayello EA. CE: Pressure Injuries Caused by Medical Devices and Other Objects: A Clinical Update. Am J Nurs. 2017 Dec;117(12):36-45. doi: 10.1097/01.NAJ.0000527460.93222.31.
Results Reference
result
Learn more about this trial
The Effect of Care Bundle in Preventing Pressure Ulcers Caused by Medical Devices in the Pediatric Intensive Care Unit
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