NCT03770104

Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room

Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room According to Two Different Methods Based on Estimated Birth Weight. Randomized Clinical Trial (NeoTEDI)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Tania Carbayo Jiménez · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Not accepted

Summary

The investigators wished to determine whether estimating endotracheal tube (ETT) insertion depth using the formula given by Spanish guidelines recommendations (5,5 plus weight) rather than the depth using the formula given by international guidelines recommendations (6 plus weight) resulted in more correctly positioned endotracheal tube tips in newborns intubated in the delivery room.

Detailed description

A number of different methods have been used to guide clinicians in estimating the correct depth of insertion of endotracheal tube (ETT) at the time of oral intubation. Minor differences in tube length may lead to intubation of the right main bronchus or extubation. However, none of them has shown to be better than others when compared in the context of randomized clinical trials. Commonly, clinicians use a formula based on the newborn's weight (Tochen formula: ETT insertion depth (cm)=6 + wt (kg)). While this method is widely used and recommended by international guidelines, it has been found to frequently result in incorrectly positioned tubes, especially in infants \<1000 g in weight in whom it may lead to overestimation of ETT insertion depth. On the other hand, Spanish Society of Neonatology recommended in their last published guidelines (2017) to use an alternative version formula (ETT insertion depth (cm)=5.5 + wt (kg)), which is commonly used among Spanish neonatal units. Finally, no studies have been performed in newborns who require oral intubation in the delivery room, since these intubations are usually excluded because infants are not routinely weighed prior to resuscitation and weight can not be rapidly obtained. Given that Obstetric Unit in our hospital is a high standard one with a highly reliable estimated fetal weight in prenatal ultrasound, the investigators will use estimated fetal weight referred on ultrasounds or 50th percentile for gestational age for calculations.

Conditions

• Intubation Complication
• Newborn Morbidity
• Cardiopulmonary Resuscitation

Interventions

Type	Name	Description
PROCEDURE	ETT insertion depth using Spanish recommendations	Infants included in this assignment group will be intubated using the formula 5.5 plus weight, when requiring oral intubation in the delivery room.
PROCEDURE	ETT insertion depth using international recommendations	Infants included in this assignment group will be intubated using the formula 6 plus weight, when requiring oral intubation in the delivery room.

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2018-12-10
• Last updated: 2021-06-16

Locations

1 site across 1 country: Spain