The Effect of Care Bundle in Preventing Pressure Ulcers Caused by Medical Devices in the Pediatric Intensive Care Unit

NCT05406986 | Unknown DMC

• 1 other identifier: Kilis7AralikUnivesity2022
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pressure Ulcer; Nursing Caries; Device Induced Injury

Keywords

medical devices; pressure ulcers; Care Bundles

Outcome Measures

Primary Outcomes (1)

• Pressure ulcer

  Medical devices related pressure ulcer

  14 day

Secondary Outcomes (1)

• medical device induced pressure ulcer

  14 day

Study Arms (2)

the group to which the care bundle will be applied

EXPERIMENTAL

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.

Other: care bundle application

group not to be interfered with

NO INTERVENTION

Patients with attached nasogastric tube, intubation tube and saturation probe.

Interventions

care bundle application OTHER

The patients in the experimental group will be given care according to the current care bundle for 14 days

the group to which the care bundle will be applied

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• being in the pediatric intensive care unit.
• nasogastric tube, intubation tube and saturation probe attached.
• Voluntary consent of family to participate in the study

You may not qualify if:

• Patients with skin disease
• Patients staying less than 14 days

Sponsors & Collaborators

• Kilis 7 Aralik University: lead

Related Publications (5)

• Butler CT. Pediatric skin care: guidelines for assessment, prevention, and treatment. Dermatol Nurs. 2007 Oct;19(5):471-2, 477-82, 485.

  PMID: 18286861 RESULT

• 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.

  PMID: 29246340 RESULT

• Freundlich K. Pressure Injuries in Medically Complex Children: A Review. Children (Basel). 2017 Apr 7;4(4):25. doi: 10.3390/children4040025.

  PMID: 28387749 RESULT

• 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.

  PMID: 32904968 RESULT

• 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.

  PMID: 29120893 RESULT

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zerrin Çiğdem

  Hasan Kalyoncu Univesity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erhan Elmaoğlu

CONTACT

+903488142666; erhan.elmaoglu@kilis.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: Experimental and control groups will be selected using the randomized control method.

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: June 7, 2022
• Study Start: July 15, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share