Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

The Effect of Replacement Frequency of Electrodes on Skin in Infant

21 oktober 2021 bijgewerkt door: Zehra Kan Onturk, Acibadem University

The Effect of Replacement Frequency of Electrodes on Skin Moisture and Condition in Infants Hospitalized in the Pediatric Intensive Care Unit

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The study was conducted with 66 participants, with the number of participants being 33 in both two groups (Experimental and Control Group).The randomization of the sample was determined by entering the total number of cases in line with the Research Randomizer program.

The control group of the study involved infants whose monitoring electrodes were replaced at the 24th hour after being monitored and the experimental group involved infants whose monitoring electrodes were replaced at the 12th and 24th hour after being monitored.

Before all participants are monitored, skin cleansing was performed on the right second intercostal space (Right 2nd ICA), left second intercostal space (Left 2nd ICA) and the left lower side of the sternum at the left midclavicular level in the fifth intercostal space (Midclavicular 5th ICA). After that, skin moisture was measured where monitoring will be performed and skin condition evaluation of these areas. Then the participants were monitored.

After these applications, skin moisture and skin condition score evaluations were repeated in both groups.

Skin Condition Score The skin condition score, developed by the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) and validated by Calisir et al. in 2016, was used to determine the skin condition. 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. Permission was obtained for the use of the skin condition score from the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) and the authors who performed the Turkish validity and reliability.

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%), because of its fast, easy and reliable use, low cost, and its ability to measure in many anatomical regions.

Materials provided in accordance with the procurement procedure of the institution where the research was conducted and used in patient care during the data collection phase were preferred as consumable materials.

Researchers do not have any conflict of interest with companies regarding the preference of these materials. The consumables that are still used in the institution.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

33

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Kalkoen
      • Istanbul, Kalkoen
        • Acıbadem University Atakent Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

1 maand tot 1 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Control group (replacement every 24 hours)
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

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.
Experimenteel: Experimental Group (replacement every 12 hours)
In the experimental group, the monitoring electrodes were replacement every 12 hours within 24 hours.
Procedure: Replacement every 12 hours

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in skin moisture
Tijdsspanne: 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.

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
Tijdsspanne: 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.
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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Acibadem University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 augustus 2018

Primaire voltooiing (Werkelijk)

17 juni 2019

Studie voltooiing (Werkelijk)

17 juni 2019

Studieregistratiedata

Eerst ingediend

16 augustus 2021

Eerst ingediend dat voldeed aan de QC-criteria

16 augustus 2021

Eerst geplaatst (Werkelijk)

23 augustus 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 oktober 2021

Laatste update ingediend die voldeed aan QC-criteria

21 oktober 2021

Laatst geverifieerd

1 oktober 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • ATADEK-2018/11

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren