The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation

NCT06832553 | Recruiting

• 1 other identifier: 2024/101
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm

Keywords

preterm

Outcome Measures

Primary Outcomes (1)

• demographic data

  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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• skin ph meter and skin moisture meter

  through study completion, an average of 1 year

Other Outcomes (2)

• Newborn Skin Condition Assessment Scale

  through study completion, an average of 1 year

• unplanned extubation

  through study completion, an average of 1 year

Study Arms (2)

Surgical Incision Drape

EXPERIMENTAL

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.

Other: surgical incision drep

silk plasters

ACTIVE COMPARATOR

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.

Other: surgical incision drep

Interventions

surgical incision drep OTHER

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

Also known as: silk plasters

Surgical Incision Drape; silk plasters

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Barış Çelik

Batman, 72000, Turkey (Türkiye)

RECRUITING

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

• Barış Çelik

  Hasan Kalyoncu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barış Çelik

CONTACT

5424283452; c.celikbaris@gmail.com

Ayla Yava

CONTACT

05372419171; ayla.yava@hku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd student

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: February 18, 2025
• Study Start: October 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: July 15, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

TU (1)