RecruitingACTRN12607000186459

Does the use of an introducer (stylet) improve the success rate at orotracheal intubation in newborn infants?

Sponsor

Royal Women's Hospital, Carlton, Victoria

Enrollment

300 participants

Start Date

Aug 1, 2006

Study Type

Interventional

Conditions

Orotracheal Intubation of Newborn Infants

Summary

Orotracheal intubation of newborn infants requiring respiratory support is difficult and often requires multiple attempts. Oral intubation may be performed using an endotracheal tube on its own or with an introducer (stylet) to help guide the insertion. We hypothesise that intubation is more frequently successful and performed quicker using an endotracheal tube with an introducer (stylet) than without and may be the preferred method of intubating newborn infants.

Eligibility

Sex: Both males and femalesMax Age: 16 Weekss

Plain Language Summary

Simplified for easier understanding

This study is for newborn babies who need a breathing tube inserted through the mouth (orotracheal intubation) to help them breathe. Inserting a breathing tube in a newborn is technically difficult, often requiring multiple attempts, and faster success reduces distress and risk to the baby. The study tests whether using a thin guiding wire (called a stylet or introducer) inside the breathing tube makes insertion more successful and quicker compared to doing it without the stylet. You may be eligible if: - Your baby is a newborn (up to term corrected age, or up to 16 weeks of postnatal life) who needs a breathing tube for ventilatory support You may NOT be eligible if: - Your baby's condition does not allow enough time to complete the randomisation process before the tube must be inserted Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Newborn infants who require intubation and ventilation, from birth until time of discharge from the level 3 neonatal unit, as deemed necessary by the attending doctor will be randomised to intubation

Newborn infants who require intubation and ventilation, from birth until time of discharge from the level 3 neonatal unit, as deemed necessary by the attending doctor will be randomised to intubation with (intervention group) an introducer (stylet). A single intubation attempt should usually take no longer than 60 seconds but multiple attempts are often reuired. For the purposes of this study only the first attempt will be randomised. The duration of ventilation will be determined by the doctor responsible for the infant and is not an outcome in this study.

Locations(1)

Australia

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ACTRN12607000186459