Using surgical drapes to secure endotracheal tubes in preterm infants
The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation in Neonatal Preterm Infants: A Randomized Controlled Trial
This study is testing if using surgical drapes to hold endotracheal tubes in place can help preterm infants avoid accidental tube removal and skin damage compared to regular methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 28 Weeks to 34 Weeks |
| Sex | All |
| Sponsor | Hasan Kalyoncu University Academic / other |
| Locations | 1 site (Batman) |
| Trial ID | NCT06832553 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of surgical incision drapes for securing endotracheal tubes in preterm neonates. Conducted as a randomized controlled trial, participants will be divided into two groups: one using the surgical drape and the other using standard fixation methods. The study will focus on minimizing unplanned extubation and skin damage by measuring skin moisture, pH, and assessing skin condition in both groups. Data will be collected every 24 hours during the intubation period to evaluate the outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants between 28-34 weeks of gestation who are hospitalized and intubated in a neonatal intensive care unit.
Not a fit: Patients with congenital skin conditions, circulatory problems, or those intubated for less than 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications related to endotracheal tube fixation in preterm infants.
How similar studies have performed: While similar approaches have been explored, this specific use of surgical drapes in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Batman
- Barış Çelik — Batman, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Barış Çelik — Hasan Kalyoncu University
- Study coordinator: Barış Çelik
- Email: c.celikbaris@gmail.com
- Phone: 5424283452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.