The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation
ConditionPreterm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-34
SponsorHasan Kalyoncu University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Congenital skin condition,
With circulatory problems,
Congenital anomalies and metabolic disorders,
Small for gestational age (SGA) and large for gestational age (LGA),
Trial design
Design model
Parallel
Treatments tested in this trial
surgical incision drep
Other interventionTo compare the efficacy of surgical incision with silk plaster in ETT fixation.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Surgical Incision DrapeExperimental treatment 1 intervention
Group B: silk plastersActive comparator 1 intervention
Trial outcomes
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.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
skin ph meter and skin moisture meter
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.
Time frame
through study completion, an average of 1 yearOther outcomes
1
Newborn Skin Condition Assessment Scale
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.
Time frame
through study completion, an average of 1 year2
unplanned extubation
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov