Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room (Intubated-DR)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Intubation Complication; Cardiopulmonary Resuscitation; Newborn Morbidity
• Intervention / Treatment: Procedure: ETT insertion depth using Spanish recommendations; Procedure: ETT insertion depth using international recommendations

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.

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tania Carbayo Jimenez, M.D.; Phone Number: 0034 91 390 8272; Email: tania.carbayo@salud.madrid.org
• Study Contact Backup: Name: Carmen Rosa Pallás Alonso, M.D.; Ph.D.; Phone Number: 0034 913908273; Email: carmenrosa.pallas@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre. Neonatology Department.
    • Contact: María Soriano-Ramos, M.D.; Phone Number: 0034 91390 8272

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (5.5 plus weight); ETT insertion depth using Spanish recommendations Patients included in the intervention group arm who are included in the study will be intubated using Spanish recommendations (5.5 plus weight) to estimate insertion endotracheal tube depth. In addition, every arm will be divided into 2 subgroups depending on gestational age (under 32 weeks or equal/over 32 weeks' gestation).	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.
Experimental: Control Group (6 plus weight); ETT insertion depth using international recommendations Patients included in the intervention group arm who are included in the study will be intubated using international recommendations (6 plus weight) to estimate insertion endotracheal tube depth. In addition, every arm will be divided into 2 subgroups depending on gestational age (under 32 weeks or equal/over 32 weeks' gestation).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intubation attempts in the delivery room	Number of intubation attempts in the delivery room by healthcare professionals	2 days
Number of accidental extubations prior to chest X-ray	Number of accidental extubations prior to chest X-ray confirmation of ETT position	2 days
Frequency of ETT repositioning prior and after chest X-ray	ETT repositioning prior and after chest X-ray	2 days
Frequency of incorrect ETT position	Incorrect ETT position (too low or too high)	2 days
Frequency of complications secondary to incorrect ETT position	Complications secondary to incorrect ETT position (air leak, unplanned extubation, atelectasis)	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	1 day
Duration of ventilation	Duration of ventilation in days	3 months
Oxygen therapy at 28 days	Oxygen therapy at 28 days	1 month
Oxygen therapy at 36 weeks postmenstrual age	Oxygen therapy at 36 weeks postmenstrual age	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of intraventricular hemorrhage or central nervous system lesion	Presence of intraventricular hemorrhage or central nervous system lesion	3 months
Death before discharge from the hospital	Death before discharge from the hospital	4 months

Collaborators and Investigators

• Sponsor: Tania Carbayo Jiménez
• Investigators: Study Chair: Tania Carbayo Jimenez, M.D., Hospital Universitario 12 de Octubre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 12, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Complications; Newborn; Intubation; Delivery room
• Other Study ID Numbers: Neo TEDI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No