Confirmation of Tube Placement in Newborns
- Conditions
- Respiratory Distress SyndromeApnea of Newborn
- Interventions
- Procedure: Vocal cord markingProcedure: Nostril-Tragus-Length
- Registration Number
- NCT05229887
- Lead Sponsor
- University of Alberta
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- Infants will be excluded if their parents refuse to give consent to this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vocal cord markings Vocal cord marking - Nostril-Tragus-Length Nostril-Tragus-Length -
- Primary Outcome Measures
Name Time Method Number of endotracheal tubes correctly placed within the trachea within 30 minutes after endotracheal intubation
- Secondary Outcome Measures
Name Time Method Duration of Intubation procedure 0 to 60 seconds During 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 seconds 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
Mortality in the Neonatal Intensive Care Unit 0-200 days We will record the number of infants who die during their admission
Bronchopulmonary Dysplasia at 36 weeks corrected gestational age We will record the number of infants who are diagnosed with Bronchopulmonary Dysplasia
Changes in Heart rate during intubation procedure 0 to 60 seconds During intubation we will record the lowest heart rate.
Necrotizing Enterocolitis 0-200 days We will record the number of infants who are diagnosed with Necrotizing Enterocolitis
Patent Ductus Arteriosus 0-200 days We will record the number of infants who are diagnosed with Patent Ductus Arteriosus
Changes in oxygen saturation during intubation procedure 0 to 60 seconds During intubation we will record the lowest oxygen saturation
Intraventricular hemorrhage all grades 0-200 days We will record the number of infants who are diagnosed with intraventricular hemorrhage
Trial Locations
- Locations (1)
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada