Clinical trial NCT06832553: The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation
Official title: The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation in Neonatal Preterm Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm
Keywords: preterm
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 110
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: demographic data
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: skin ph meter and skin moisture meter
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Newborn Skin Condition Assessment Scale
timeFrame: through study completion, an average of 1 year
measure: unplanned extubation
timeFrame: through study completion, an average of 1 year
Locations:
city: Batman
country: Turkey
facility: Barış Çelik
Study officials:
affiliation: Hasan Kalyoncu University
name: Barış Çelik
role: PRINCIPAL_INVESTIGATOR
References: