Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room

Intubation Complication Clinical Trial

— Intubated-DR  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03770104
• Other study ID #: Neo TEDI
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 2022

Study information

• Verified date: June 2021
• Source: Hospital Universitario 12 de Octubre
• Contact: Tania Carbayo Jimenez, M.D.
• Phone: 0034 91 390 8272
• Email: tania.carbayo[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Resuscitation
• Intubation Complication
• Newborn Morbidity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre. Neonatology Department.	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Tania Carbayo Jiménez

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence of intraventricular hemorrhage or central nervous system lesion	Presence of intraventricular hemorrhage or central nervous system lesion	3 months
Other	Death before discharge from the hospital	Death before discharge from the hospital	4 months
Primary	Frequency 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.	1 hour
Secondary	Number of intubation attempts in the delivery room	Number of intubation attempts in the delivery room by healthcare professionals	2 days
Secondary	Number of accidental extubations prior to chest X-ray	Number of accidental extubations prior to chest X-ray confirmation of ETT position	2 days
Secondary	Frequency of ETT repositioning prior and after chest X-ray	ETT repositioning prior and after chest X-ray	2 days
Secondary	Frequency of incorrect ETT position	Incorrect ETT position (too low or too high)	2 days
Secondary	Frequency of complications secondary to incorrect ETT position	Complications secondary to incorrect ETT position (air leak, unplanned extubation, atelectasis)	7 days
Secondary	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	1 day
Secondary	Duration of ventilation	Duration of ventilation in days	3 months
Secondary	Oxygen therapy at 28 days	Oxygen therapy at 28 days	1 month
Secondary	Oxygen therapy at 36 weeks postmenstrual age	Oxygen therapy at 36 weeks postmenstrual age	3 months