Confirmation of Tube Placement in Newborns

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.

Study Overview

• Status: Withdrawn
• Conditions: Respiratory Distress Syndrome; Apnea of Newborn
• Intervention / Treatment: Procedure: Nostril-Tragus-Length; Procedure: Vocal cord marking

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nostril-Tragus-Length	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.
Experimental: Vocal cord markings	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Georg Schmolzer, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: Pro00116201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators can contact the PI to discuss to use the collected data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

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