Confirmation of Tube Placement in Newborns

Study Overview
=================
Brief Summary
-----------------
Tracheal intubation remains a common procedure in the neonatal intensive care unit (NICU) and the delivery room (DR). Current guidelines recommend Estimation of correct endotracheal tube (ETT) insertion Our hospital policy recommends to estimate the correct depth (cm) of tube placement by measuring the nasal-ear-tragus length using the 7-8-9 rule when the endotracheal tube is placed orally. Using this formula an infant weighing 1kg would be intubated to a depth of 7cm, a 2kg infant to a depth of 8cm, and a 3kg infant to a depth of 9cm from the upper lip. With the new 2015 guidelines, ETT depth is determined by measuring the newborn's nasal septum-tragus length (NTL) and adding 1cm or by using the initial endotracheal tube insertion depth table. The NTL is described as the distance from the base of the nasal septum to the tragus of the ear. However, studies using NTL reported that using this technique only resulted in correct ETT placement in 56% of cases. Every ETT has markings on the tube, which are called vocal cord markings, which are to be used to provide a guidance to how deep to place the ETT into the trachea. There has been npc study to compare the vocal cord markings with the current approach of NTL. The current study aims to determine if the use of vocal cord markings during intubation increases percentage of correct endotracheal tube placement compared to NTL in preterm and term infants.

Official Title
-----------------
Confirmation of Tube Placement in Newborns

Conditions
-----------------
Respiratory Distress Syndrome, Apnea of Newborn

Intervention / Treatment
-----------------
* Procedure: Nostril-Tragus-Length
* Procedure: Vocal cord marking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All infants (term and preterm) born at The Royal Alexandra Hospital who require endotracheal intubation in the delivery room or/and Neonatal Intensive Care Unit will be eligible. Exclusion Criteria: Infants will be excluded if their parents refuse to give consent to this study.

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nostril-Tragus-Length<br> | Procedure: Nostril-Tragus-Length<br>* Endotracheal tube depth is determined by measuring the newborn's nasal septum-tragus length (NTL) and adding 1cm. The NTL is described as the distance from the base of the nasal septum to the tragus of the ear.<br>|
| Experimental: Vocal cord markings<br> | Procedure: Vocal cord marking<br>* The endotracheal tube has markings on the tube, which are called vocal cord markings, which will be used to provide a guidance to how deep to place the ETT into the trachea.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of endotracheal tubes correctly placed within the trachea |  | within 30 minutes after endotracheal intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality in the Neonatal Intensive Care Unit | We will record the number of infants who die during their admission | 0-200 days | 
| Necrotizing Enterocolitis | We will record the number of infants who are diagnosed with Necrotizing Enterocolitis | 0-200 days | 
| Patent Ductus Arteriosus | We will record the number of infants who are diagnosed with Patent Ductus Arteriosus | 0-200 days | 
| Intraventricular hemorrhage all grades | We will record the number of infants who are diagnosed with intraventricular hemorrhage | 0-200 days | 
| Bronchopulmonary Dysplasia at | We will record the number of infants who are diagnosed with Bronchopulmonary Dysplasia | 36 weeks corrected gestational age | 
| Changes in oxygen saturation during intubation procedure | During intubation we will record the lowest oxygen saturation | 0 to 60 seconds | 
| Changes in Heart rate during intubation procedure | During intubation we will record the lowest heart rate. | 0 to 60 seconds | 
| Duration of Intubation procedure | During Intubation, we will measure time from end of mask ventilation to connection of the ventilation device to ETT | 0 to 60 seconds | 
| Airway injury observed during intubation (including blood, swollen cords, vocal cord redness) | Observed by the person who performs the intubation by looking for blood, swollen cords, redness. There is no score or questionnaire. The operator will only assess these with yes or no | 0 to 60 seconds |