Endotracheal Tube Placement in Neonatal Intubation

Zekai Tahir Burak Women's Health Research and Education Hospital160 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

160

Conditions

Neonatal Respiratory Failure

Interventions

Weight+6OTHER

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.

NTL+1OTHER

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.

Eligibility

Sex: ALLMin age: 1 DayMax age: 30 Days

Medical Language ↔ Plain English

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

Locations (5)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, Turkey (Türkiye)

Diyarbakır Gazi Yaşargil Training and Research Hospital

Diyarbakır, Turkey (Türkiye)

Ege University

Izmir, Turkey (Türkiye)

Izmir Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Outcomes

Primary Outcomes

Correct placement of the ETT

After 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).

Time frame: Up to 1 hour

Secondary Outcomes

Pneumothorax

Pneumothorax by transillumination confirmed by chest x-ray.

Time frame: Up to postmenstrual 52 weeks or till discharge

Bronchopulmonary displasia (BPD)

BPD will be defined according to National Institutes of Health criteria.

Time frame: Postnatal age of 28 days or till discharge

Mortality

We will record who died until discharge

Time frame: Up to postmenstrual 52 weeks or till discharge

Data from ClinicalTrials.gov

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