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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
280
Infants included in this assignment group will be intubated using the formula 5.5 plus weight, when requiring oral intubation in the delivery room.
Infants included in this assignment group will be intubated using the formula 6 plus weight, when requiring oral intubation in the delivery room.
Hospital Universitario 12 de Octubre. Neonatology Department.
Madrid, Spain
RECRUITINGFrequency of correct endotracheal tube (ETT) position
Correct ETT position, that is, tip between the upper border of the first thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on a chest X-ray as determined by one pediatric radiologist masked to group assignment.
Time frame: 1 hour
Number of intubation attempts in the delivery room
Number of intubation attempts in the delivery room by healthcare professionals
Time frame: 2 days
Number of accidental extubations prior to chest X-ray
Number of accidental extubations prior to chest X-ray confirmation of ETT position
Time frame: 2 days
Frequency of ETT repositioning prior and after chest X-ray
ETT repositioning prior and after chest X-ray
Time frame: 2 days
Frequency of incorrect ETT position
Incorrect ETT position (too low or too high)
Time frame: 2 days
Frequency of complications secondary to incorrect ETT position
Complications secondary to incorrect ETT position (air leak, unplanned extubation, atelectasis)
Time frame: 7 days
Professional healthcare sensation about correct or incorrect ETT position
Professional healthcare sensation about correct or incorrect ETT position, before confirmation with Chest X-ray confirmation
Time frame: 1 day
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Duration of ventilation
Duration of ventilation in days
Time frame: 3 months
Oxygen therapy at 28 days
Oxygen therapy at 28 days
Time frame: 1 month
Oxygen therapy at 36 weeks postmenstrual age
Oxygen therapy at 36 weeks postmenstrual age
Time frame: 3 months