Confirmation of Tube Placement in Newborns

Respiratory Distress Syndrome Clinical Trial

Official title:

Confirmation of Tube Placement in Newborns

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05229887
• Other study ID #: Pro00116201
• Status: Withdrawn
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Apnea of Newborn
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of endotracheal tubes correctly placed within the trachea		within 30 minutes after endotracheal intubation
Secondary	Mortality in the Neonatal Intensive Care Unit	We will record the number of infants who die during their admission	0-200 days
Secondary	Necrotizing Enterocolitis	We will record the number of infants who are diagnosed with Necrotizing Enterocolitis	0-200 days
Secondary	Patent Ductus Arteriosus	We will record the number of infants who are diagnosed with Patent Ductus Arteriosus	0-200 days
Secondary	Intraventricular hemorrhage all grades	We will record the number of infants who are diagnosed with intraventricular hemorrhage	0-200 days
Secondary	Bronchopulmonary Dysplasia at	We will record the number of infants who are diagnosed with Bronchopulmonary Dysplasia	36 weeks corrected gestational age
Secondary	Changes in oxygen saturation during intubation procedure	During intubation we will record the lowest oxygen saturation	0 to 60 seconds
Secondary	Changes in Heart rate during intubation procedure	During intubation we will record the lowest heart rate.	0 to 60 seconds
Secondary	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
Secondary	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