Clinical trial NCT05406986: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcer
Nursing Caries
Device Induced Injury
Keywords: medical devices
pressure ulcers
Care Bundles
Lead sponsor: Kilis 7 Aralik University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental and control groups will be selected using the randomized control method.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Pressure ulcer
timeFrame: 14 day
Secondary outcomes:
measure: medical device induced pressure ulcer
timeFrame: 14 day
Other outcomes:
Locations:
Study officials:
affiliation: Hasan Kalyoncu Univesity
name: Zerrin Çiğdem
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butler CT. Pediatric skin care: guidelines for assessment, prevention, and treatment. Dermatol Nurs. 2007 Oct;19(5):471-2, 477-82, 485.
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.
citation: Freundlich K. Pressure Injuries in Medically Complex Children: A Review. Children (Basel). 2017 Apr 7;4(4):25. doi: 10.3390/children4040025.
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.
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.