Clinical trial NCT03770104: Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation Complication
Newborn Morbidity
Cardiopulmonary Resuscitation
Keywords: Intubation
Newborn
Delivery room
Complications
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 280
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All newborns requiring endotracheal oral intubation in the delivery room after birth.
* Parents accept deferred informed consent to participate in the study.

Exclusion Criteria:

* Prior to randomization
* Uncontrolled gestation where both estimated fetal weight and gestational age are unknown.
* Upper airway anomaly or a lung anomaly that would distort the upper airway anatomy.
* Infants who require nasotracheal intubation
* Infants who are intubated in the Neonatal Intensive Care Unit
* Post-randomization
* Newborns who are randomized but finally do not require intubation
* Intubated newborns who are electively extubated in the delivery room
* Parents / legal guardian refuse to give consent to participate in the study

Primary outcomes:
measure: Frequency of correct endotracheal tube (ETT) position
timeFrame: 1 hour
Secondary outcomes:
measure: Number of intubation attempts in the delivery room
timeFrame: 2 days
measure: Number of accidental extubations prior to chest X-ray
timeFrame: 2 days
measure: Frequency of ETT repositioning prior and after chest X-ray
timeFrame: 2 days
measure: Frequency of incorrect ETT position
timeFrame: 2 days
measure: Frequency of complications secondary to incorrect ETT position
timeFrame: 7 days
measure: Professional healthcare sensation about correct or incorrect ETT position
timeFrame: 1 day
measure: Duration of ventilation
timeFrame: 3 months
measure: Oxygen therapy at 28 days
timeFrame: 1 month
measure: Oxygen therapy at 36 weeks postmenstrual age
timeFrame: 3 months
Other outcomes:
measure: Presence of intraventricular hemorrhage or central nervous system lesion
timeFrame: 3 months
measure: Death before discharge from the hospital
timeFrame: 4 months
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre. Neonatology Department.
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Tania Carbayo Jimenez, M.D.
role: STUDY_CHAIR
References:
citation: Flinn AM, Travers CP, Laffan EE, O'Donnell CP. Estimating the endotracheal tube insertion depth in newborns using weight or gestation: a randomised trial. Neonatology. 2015;107(3):167-72. doi: 10.1159/000369375.
citation: Gill I, Stafford A, Murphy MC, Geoghegan AR, Crealey M, Laffan E, O'Donnell CPF. Randomised trial of estimating oral endotracheal tube insertion depth in newborns using weight or vocal cord guide. Arch Dis Child Fetal Neonatal Ed. 2018 Jul;103(4):F312-F316. doi: 10.1136/archdischild-2017-312798. Epub 2017 Sep 7.
citation: Tochen ML. Orotracheal intubation in the newborn infant: a method for determining depth of tube insertion. J Pediatr. 1979 Dec;95(6):1050-1. doi: 10.1016/s0022-3476(79)80309-1. No abstract available.
citation: Amarilyo G, Mimouni FB, Oren A, Tsyrkin S, Mandel D. Orotracheal tube insertion in extremely low birth weight infants. J Pediatr. 2009 May;154(5):764-5. doi: 10.1016/j.jpeds.2008.11.057.
citation: Peterson J, Johnson N, Deakins K, Wilson-Costello D, Jelovsek JE, Chatburn R. Accuracy of the 7-8-9 Rule for endotracheal tube placement in the neonate. J Perinatol. 2006 Jun;26(6):333-6. doi: 10.1038/sj.jp.7211503.
citation: Kempley ST, Moreiras JW, Petrone FL. Endotracheal tube length for neonatal intubation. Resuscitation. 2008 Jun;77(3):369-73. doi: 10.1016/j.resuscitation.2008.02.002. Epub 2008 Mar 26.