Confirmation of Tube Placement in Newborns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome Apnea of Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nostril-Tragus-Length

Group Type ACTIVE_COMPARATOR

Nostril-Tragus-Length

Intervention Type PROCEDURE

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.

Vocal cord markings

Group Type EXPERIMENTAL

Vocal cord marking

Intervention Type PROCEDURE

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.

Interventions

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Vocal cord marking

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.

Intervention Type PROCEDURE

Nostril-Tragus-Length

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.