The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation

Hasan Kalyoncu University

Status: Enrolling

Conditions: Preterm

Treatments: Other: surgical incision drep

Study type: Interventional

Funder types: Other

Identifiers

NCT06832553

2024/101

Details and patient eligibility

About

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.

Full 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).

Enrollment: 110 estimated patients

Sex: All

Ages: 28 to 34 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Surgical Incision Drape

Experimental group

Description:

Participants in this group will have their endotracheal tube (ETT) secured using a surgical incision drape. This method will be evaluated for its efficacy in preventing unplanned extubation and wound complications compared to the use of silk plasters.

Treatment:

Other: surgical incision drep

silk plasters

Active Comparator group

Description:

The endotracheal tube (ETT) of the participants in this group will be secured using silk plasters. This method will be evaluated for its efficacy in preventing unplanned extubation and wound complications compared to the use of a surgical incision drape.

Treatment:

Other: surgical incision drep