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NCT Number: NCT06832553

The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation

It is aimed to minimise both unplanned extubation and skin damage with the surgical incision drep that we will use to fix the endotracheal tube in neonatal preterm infants and to reduce the complications that may develop due to these events. In addition, it is aimed to evaluate the relationship between these parameters by using devices measuring skin moisture, skin pH and Neonatal Skin Condition Assessment Scale in experimental and control groups.

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Key information

Conditions

Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

28 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barış Çelik

Batman, 72000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Barış Çelik

CONTACT

[email protected]

About this study

The aim of this study is to investigate the effectiveness of surgical incision drape usage for securing endotracheal tubes in preterm neonates. The study will be conducted using a randomized controlled design, and participants will be divided into two groups: those using the surgical drape and those not using it. The population of the study will consist of preterm infants who are hospitalised in the neonatal intensive care unit of Batman Training and Research Hospital. Intubated preterm infants between 28-34 weeks will be included in the study regardless of gender difference. Research data will be collected by the following methods: Demographic information, Neonatal Skin Condition Rating Scale (NSCS), Skin Ph meter device and skin moisture meter device. Data will be collected every 24 hours during the intubation period. The results of the study are expected to provide important theoretical and practical contributions. The effects of parameters such as skin wounds that may occur due to endotracheal tube fixation in infants, unplanned extubation rates, skin pH and skin moisture at the site of intubation fixation will be compared between the surgical incision drep and the standard group. The research data will be analysed using IBM SPSS 27.0 Programme (Statistical Package for Social Sciences).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants between 28-34 weeks of gestation hospitalized in neonatal intensive care unit,
  • Intubated infants on invasive mechanical ventilators,
  • Babies who were orally intubated were included in the study.

Exclusion criteria

  • Congenital skin condition,
  • With circulatory problems,
  • Congenital anomalies and metabolic disorders,
  • Small for gestational age (SGA) and large for gestational age (LGA),
  • Unplanned extubation taking place,
  • Babies intubated for less than 24 hours will be excluded from the study.

Treatment and study plan

surgical incision drep

Other

To compare the efficacy of surgical incision with silk plaster in ETT fixation.

Other names: silk plasters

Primary outcomes

  1. demographic data

    Time frame: through study completion, an average of 1 year

    It will consist of questions such as gestational week, birth weight, postnatal age, frequency of endotracheal tube re-fixation, reason for hospitalization, frequency of aspiration, mode of delivery, gender, phototherapy status, antibiotic status, sedative use, analgesic use, ventilator mode.

Secondary outcomes

  1. skin ph meter and skin moisture meter

    Time frame: through study completion, an average of 1 year

    During the intubation period, skin pH and skin moisture meter data will be obtained from the experimental and control group patients every 24 hours at the intubation fixation site.

Other outcomes

  1. Newborn Skin Condition Assessment Scale

    Time frame: through study completion, an average of 1 year

    Data will be collected every 24 hours.The scale consists of three dimensions including dryness, redness and impaired skin integrity/peeling. The NSCS can be used in all newborns and a score between 3 and 9 is obtained. The lowest score of 3 indicates the best skin score, while the highest score of 9 indicates the worst skin score. skin wounds scores at the site of intubation tube fixation will be compared in experimental and control groups.

  2. unplanned extubation

    Time frame: through study completion, an average of 1 year

    Data will be collected and statistical values will be calculated when an unplanned extubation event occurs in the experimental and control group patients while the patient is intubated.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayla Yava

CONTACT

[email protected]

05372419171

Barış Çelik

CONTACT

[email protected]

5424283452

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation in Neonatal Preterm Infants: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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