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Endotracheal Tube Placement in Neonatal Intubation

Is Nasal Septum-tragus Length Safe in Neonatal Endotracheal Intubation?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03591835
Enrollment
160
Registered
2018-07-19
Start date
2018-01-15
Completion date
2018-09-01
Last updated
2018-12-11

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

Conditions

Neonatal Respiratory Failure

Keywords

Nasal septum-tragus length; newborn

Brief summary

Endotracheal intubation is a frequent procedure performed in neonates with respiratory distress. Clinicians use different methods to estimate the intubation insertion depth. In this study, the investigators aimed to compare the two different methods (kilogram + 6 cm and nasal septum-tragus length (NTL) + 1 cm) used to determine the endotracheal intubation insertion depth.

Detailed description

Endotracheal intubation is a frequent procedure performed in neonates with respiratory distress. The ideal location of the tube is between the top of the 1st thoracic vertebra and the bottom of the 2nd thoracic vertebra in the X-ray. Clinicians use different methods to estimate the intubation insertion depth. In this study, investigators aimed to compare the two different methods (kilogram+6 cm and nasal septum-tragus length (NTL)+ 1 cm) used to determine the endotracheal intubation insertion depth. In this multicentre randomized prospective study, infants who had intubation indications in neonatal intensive care unit will be enrolled. The intubation tube will be fixed at the lip level using the Tochen formula (Group 1) or the NTL+1 cm formula (Group 2). The same brand endotracheal tubes will be used and after intubation the chest radiograph will be performed in the neutral position. Chest X-ray will be evaluated blindly by a single radiologist in the digital environment (above T1, in place and below T2).

Interventions

OTHERWeight+6

For the Tochen formula in Group 1, ETT depth will be calculated by taking the infant's actual weight within the last 24 h and adding 6 cm.

OTHERNTL+1

The infants in Group 2 will be intubated by measuring the NTL, the distance from the basement of the nasal septum to the the tragus of the ear. Measurements will be recorded as centimeters.

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Masking description

The radiologist who will determine endotracheal tube placement in the X-ray

Eligibility

Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No

Inclusion criteria

. * Infants who had intubation indications (cardiopulmonary failure, respiratory distress or surfactant administration) in the neonatal intensive care unit

Exclusion criteria

* Craniofacial, vertebral and genetic anomalies * Those whose parents decline consent

Design outcomes

Primary

MeasureTime frameDescription
Correct placement of the ETTUp to 1 hourAfter intubation a portable chest radiograph with digitalized measurements will be obtained to document ETT position. Head at the time of the radiograph will be stabilized in the neutral position. Chest X-ray will be evaluated blindly by a single radiologist in the digital environment (above upper border of T1, in place and below lower border of T2).

Secondary

MeasureTime frameDescription
PneumothoraxUp to postmenstrual 52 weeks or till dischargePneumothorax by transillumination confirmed by chest x-ray.
Bronchopulmonary displasia (BPD)Postnatal age of 28 days or till dischargeBPD will be defined according to National Institutes of Health criteria.
MortalityUp to postmenstrual 52 weeks or till dischargeWe will record who died until discharge

Countries

Turkey (Türkiye)

Outcome results

None listed

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