The Effect of Replacement Frequency of Electrodes on Skin in Infant

NCT05016167 | Completed

• 1 other identifier: ATADEK-2018/11
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

In the Pediatric Intensive Care Unit (PICU), each child and infant is monitored to determine the status of the underlying disease by constantly monitoring the main variables, to help diagnosis and to guide treatment. During the monitoring application, electrodes of appropriate size for the patient's age and body surface are attached to the appropriate areas of the patient where skin integrity is intact, clean, and dry. It is recommended that these electrodes be replaced within 24 hours at most, but there is no evidence of the effect of electrode replacement frequency on skin moisture and integrity. Based on this reason, this study was conducted experimentally in a randomized controlled manner to determine the effect of frequency of monitoring electrode replacement on skin moisture and condition of infants hospitalized in the PICU.

Conditions

Infant, Premature

Keywords

Infant; Moisture; Monitoring; Pediatric Intensive Care; Skin

Outcome Measures

Primary Outcomes (2)

• Change in skin moisture

  Digital Moisture Monitor For Skin was used to measure skin moisture. This moisture measuring device measures with "%". This device developed for precise measurement has been preferred because of its ability to show the amount of moisture by the contact without damaging the skin, being portable, working with a battery, having a wide measurement range (it can measure the amount of skin moisture from 0% to 99.9%). As the moisture in the skin increases, the % increases. Skin moisture measurement was made in the right 2nd ICA, left 2nd ICA, and midclavicular 5th ICA regions.

  Data collected immediately before monitoring, after monitoring 12th hour (only for experimental group) and after 24 th hours. The change in these time intervals assessed.

• Change in skin condition

  Skin condition were evaluated with the Skin Condition Assessment Scale. The scale consists of three items and each item includes an evaluation criterion. These are dryness, erythema, and skin integrity breakdown/peeling, respectively. Each item of the 3-point Likert scale gets 1 to 3 points. The lowest score that can be obtained from the scale is 3, the highest score is 9. A high total score indicates that the skin condition of the newborn is poor.

  Data collected immediately before monitoring, after monitoring 12th hour (only for experimental group) and after 24 th hours. The change in these time intervals assessed.

Study Arms (2)

Control group (replacement every 24 hours)

OTHER

The monitoring electrodes were not replaced for 24 hours, the electrodes were removed at the end of 24 hours (the protocol currently used in the institution) in control group.

Procedure: Replacement every 24 hours

Experimental Group (replacement every 12 hours)

EXPERIMENTAL

In the experimental group, the monitoring electrodes were replacement every 12 hours within 24 hours.

Procedure: Replacement every 12 hours

Interventions

Replacement every 24 hours PROCEDURE

Processing Steps: 1. The monitoring electrodes were not replaced for 24 hours, the electrodes were removed at the end of 24 hours. During the 24-hour follow-up, patients whose electrodes were removed for any reason were excluded from the sample. 2. Immediately after the drying, skin moisture measurement was made in the right 2nd intercostal space (ICA), left 2nd ICA, and midclavicular 5th ICA regions. 3. The skin condition was evaluated from the areas monitored using the skin condition score by the researcher and another independent observer. 4. The data were recorded.

Control group (replacement every 24 hours)

Replacement every 12 hours PROCEDURE

Processing Steps: 1. Monitoring electrodes were removed at the end of the 12th hour. When removing the monitoring electrodes, the area was first wetted using a disinfectant and dried using a sponge after removing the electrodes. 2. Immediately after the drying, skin moisture measurement was made in the right 2nd ICA, left 2nd ICA and midclavicular 5th ICA regions. 3. The skin condition was evaluated from these areas monitored using the skin condition score by the researcher and another independent observer. 4. Monitored again. 5. Monitoring electrodes were removed at the end of the 24th hour. Cleaning and drying were done immediately after removal. 6. Immediately after drying, skin moisture was measured from the monitored areas. 7. The skin condition was evaluated from the areas monitored using the skin condition score by the researcher and another independent observer. 8. The data were recorded.

Experimental Group (replacement every 12 hours)

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients whose parents agreed to participate in the study and signed the informed consent form
• No history of surgical procedures
• Recently admitted to the unit and monitored for the first time
• Infants aged ≥ 1 to 12 ≤ months

You may not qualify if:

• Infants with a skin disease, with other diseases that can affect skin moisture and condition, with immune system disease

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University Atakent Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

• Flodgren G, Conterno LO, Mayhew A, Omar O, Pereira CR, Shepperd S. Interventions to improve professional adherence to guidelines for prevention of device-related infections. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD006559. doi: 10.1002/14651858.CD006559.pub2.

  PMID: 23543545 RESULT

• Gray M, Black JM, Baharestani MM, Bliss DZ, Colwell JC, Goldberg M, Kennedy-Evans KL, Logan S, Ratliff CR. Moisture-associated skin damage: overview and pathophysiology. J Wound Ostomy Continence Nurs. 2011 May-Jun;38(3):233-41. doi: 10.1097/WON.0b013e318215f798.

  PMID: 21490547 RESULT

• Voegeli D. Prevention and management of moisture-associated skin damage. Nurs Stand. 2019 Jan 25;34(2):77-82. doi: 10.7748/ns.2019.e11314.

  PMID: 31468844 RESULT

• Delmore B, Deppisch M, Sylvia C, Luna-Anderson C, Nie AM. Pressure Injuries in the Pediatric Population: A National Pressure Ulcer Advisory Panel White Paper. Adv Skin Wound Care. 2019 Sep;32(9):394-408. doi: 10.1097/01.ASW.0000577124.58253.66.

  PMID: 31436620 RESULT

• Widiati E, Nurhaeni N, Gayatri D. Medical-Device Related Pressure Injuries to Children in the Intensive Care Unit. Compr Child Adolesc Nurs. 2017;40(sup1):69-77. doi: 10.1080/24694193.2017.1386973.

  PMID: 29166186 RESULT

• Jackson D, Sarki AM, Betteridge R, Brooke J. Medical device-related pressure ulcers: A systematic review and meta-analysis. Int J Nurs Stud. 2019 Apr;92:109-120. doi: 10.1016/j.ijnurstu.2019.02.006. Epub 2019 Feb 10.

  PMID: 30782513 RESULT

• Demirci K, Ugur E, Onturk ZK. Replacing Monitoring Electrodes on Infant Skin Every 12 Versus 24 Hours. Adv Skin Wound Care. 2023 Aug 1;36(8):1-8. doi: 10.1097/ASW.0000000000000010.

  PMID: 37471452 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Zehra Kan Onturk, Assist Prof

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 23, 2021
• Study Start: August 31, 2018
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)