Clinical trial NCT05229887: Confirmation of Tube Placement in Newborns
Official title: Confirmation of Tube Placement in Newborns
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Respiratory Distress Syndrome
Apnea of Newborn
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 0
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of endotracheal tubes correctly placed within the trachea
timeFrame: within 30 minutes after endotracheal intubation
Secondary outcomes:
measure: Mortality in the Neonatal Intensive Care Unit
timeFrame: 0-200 days
measure: Necrotizing Enterocolitis
timeFrame: 0-200 days
measure: Patent Ductus Arteriosus
timeFrame: 0-200 days
measure: Intraventricular hemorrhage all grades
timeFrame: 0-200 days
measure: Bronchopulmonary Dysplasia at
timeFrame: 36 weeks corrected gestational age
measure: Changes in oxygen saturation during intubation procedure
timeFrame: 0 to 60 seconds
measure: Changes in Heart rate during intubation procedure
timeFrame: 0 to 60 seconds
measure: Duration of Intubation procedure
timeFrame: 0 to 60 seconds
measure: Airway injury observed during intubation (including blood, swollen cords, vocal cord redness)
timeFrame: 0 to 60 seconds
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Georg Schmolzer
role: PRINCIPAL_INVESTIGATOR
References: