Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room

Study Overview
=================
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.

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)

Conditions
-----------------
Intubation Complication, Newborn Morbidity, Cardiopulmonary Resuscitation

Intervention / Treatment
-----------------
* Procedure: ETT insertion depth using Spanish recommendations
* Procedure: ETT insertion depth using international recommendations


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 1 Day

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (5.5 plus weight)<br>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<br>* Infants included in this assignment group will be intubated using the formula 5.5 plus weight, when requiring oral intubation in the delivery room.<br>|
| Experimental: Control Group (6 plus weight)<br>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<br>* Infants included in this assignment group will be intubated using the formula 6 plus weight, when requiring oral intubation in the delivery room.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intubation, Newborn, Delivery room, Complications