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Confirmation of Tube Placement in Newborns

Confirmation of Tube Placement in Newborns

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05229887
Enrollment
0
Registered
2022-02-08
Start date
2022-07-04
Completion date
2025-03-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea of Newborn, Respiratory Distress Syndrome

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.

Interventions

PROCEDURENostril-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.

PROCEDUREVocal 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.

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of endotracheal tubes correctly placed within the tracheawithin 30 minutes after endotracheal intubation

Secondary

MeasureTime frameDescription
Necrotizing Enterocolitis0-200 daysWe will record the number of infants who are diagnosed with Necrotizing Enterocolitis
Patent Ductus Arteriosus0-200 daysWe will record the number of infants who are diagnosed with Patent Ductus Arteriosus
Intraventricular hemorrhage all grades0-200 daysWe will record the number of infants who are diagnosed with intraventricular hemorrhage
Bronchopulmonary Dysplasia at36 weeks corrected gestational ageWe will record the number of infants who are diagnosed with Bronchopulmonary Dysplasia
Mortality in the Neonatal Intensive Care Unit0-200 daysWe will record the number of infants who die during their admission
Changes in Heart rate during intubation procedure0 to 60 secondsDuring intubation we will record the lowest heart rate.
Duration of Intubation procedure0 to 60 secondsDuring Intubation, we will measure time from end of mask ventilation to connection of the ventilation device to ETT
Airway injury observed during intubation (including blood, swollen cords, vocal cord redness)0 to 60 secondsObserved 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
Changes in oxygen saturation during intubation procedure0 to 60 secondsDuring intubation we will record the lowest oxygen saturation

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026