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

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

Inclusion Criteria1

  • All newborn infants requiring orotracheal intubation for ventilatory support from birth until discharge from the level 3 neonatal unit. This may include infants up to term gestation corrected (up to 16 weeks of postnatal life).

Exclusion Criteria1

  • Excluded if infant's condition does not allow time for randomisation.

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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