Confirmation of Tube Placement in Newborns

NCT05229887 | Withdrawn DMC

• 1 other identifier: Pro00116201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome; Apnea of Newborn

Outcome Measures

Primary Outcomes (1)

• Number of endotracheal tubes correctly placed within the trachea

  within 30 minutes after endotracheal intubation

Secondary Outcomes (9)

• Mortality in the Neonatal Intensive Care Unit

  0-200 days

• Necrotizing Enterocolitis

  0-200 days

• Patent Ductus Arteriosus

  0-200 days

• Intraventricular hemorrhage all grades

  0-200 days

• Bronchopulmonary Dysplasia at

  36 weeks corrected gestational age

Study Arms (2)

Nostril-Tragus-Length

ACTIVE COMPARATOR

Procedure: Nostril-Tragus-Length

Vocal cord markings

EXPERIMENTAL

Procedure: Vocal cord marking

Interventions

Nostril-Tragus-Length 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.

Nostril-Tragus-Length

Vocal cord marking 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.

Vocal cord markings

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infants will be excluded if their parents refuse to give consent to this study.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Georg Schmolzer

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 8, 2022
• Study Start: July 4, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

CA (1)