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Completed

NCT Number: NCT03591835

Endotracheal Tube Placement in Neonatal Intubation

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.

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Key information

Conditions

Neonatal Respiratory Failure

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey (Türkiye)

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight+6

Other

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+1

Other

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.

Primary outcomes

  1. Correct placement of the ETT

    Time frame: Up to 1 hour

    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).

Secondary outcomes

  1. Pneumothorax

    Time frame: Up to postmenstrual 52 weeks or till discharge

    Pneumothorax by transillumination confirmed by chest x-ray.

  2. Bronchopulmonary displasia (BPD)

    Time frame: Postnatal age of 28 days or till discharge

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

  3. Mortality

    Time frame: Up to postmenstrual 52 weeks or till discharge

    We will record who died until discharge

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2018
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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