The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Hydrocolloid to Prevent Nasal Injuries in Preterm Infants

NCT06325215

Pressure Injury

COMPLETED NA

Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies

NCT06246864

Neonatal Skin Conditions

NOT_YET_RECRUITING NA

Follow-up Results of Newborns With Tracheostomy

NCT04497740

Premature Tracheostomy Complication Bronchopulmonary Dysplasia

UNKNOWN

The Effect of Hydrocolloid Tape and Facial Massage in Premature Infants During Noninvasive Mechanical Ventilation

NCT05844345

Nasal Injury

UNKNOWN NA

Electrical Activity of Diaphragm as a Means to Predict Extubation Success in Preterm Infants

NCT02144363

Respiratory Distress Syndrome

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgical Incision Drape

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.

Group Type EXPERIMENTAL

surgical incision drep

Intervention Type OTHER

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

silk plasters

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.

Group Type ACTIVE_COMPARATOR

surgical incision drep

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

surgical incision drep

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

silk plasters

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes