An interventional study of Nostril-Tragus-Length and Vocal cord marking in Respiratory Distress Syndrome and Apnea of Newborn, sponsored by University of Alberta. Withdrawn at 1 site in Canada. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
Procedure: Nostril-Tragus-Length
Procedure: Vocal cord marking
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.
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.
Number of endotracheal tubes correctly placed within the trachea
Time frame: within 30 minutes after endotracheal intubation
Mortality in the Neonatal Intensive Care Unit
We will record the number of infants who die during their admission
Time frame: 0-200 days
Necrotizing Enterocolitis
We will record the number of infants who are diagnosed with Necrotizing Enterocolitis
Time frame: 0-200 days
Patent Ductus Arteriosus
We will record the number of infants who are diagnosed with Patent Ductus Arteriosus
Time frame: 0-200 days
Intraventricular hemorrhage all grades
We will record the number of infants who are diagnosed with intraventricular hemorrhage
Time frame: 0-200 days
Bronchopulmonary Dysplasia at
We will record the number of infants who are diagnosed with Bronchopulmonary Dysplasia
Time frame: 36 weeks corrected gestational age
Changes in oxygen saturation during intubation procedure
During intubation we will record the lowest oxygen saturation
Time frame: 0 to 60 seconds
Changes in Heart rate during intubation procedure
During intubation we will record the lowest heart rate.
Time frame: 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
Time frame: 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
Time frame: 0 to 60 seconds
Plan to share: Yes — Investigators can contact the PI to discuss to use the collected data
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
University of Alberta