Endotracheal Tube Placement in Neonatal Intubation

NCT03591835 | Completed

• 1 other identifier: TEP2018133
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 5

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.

Conditions

Neonatal Respiratory Failure

Keywords

Nasal septum-tragus length; newborn

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 1 hour

Secondary Outcomes (3)

• Pneumothorax

  Up to postmenstrual 52 weeks or till discharge

• Bronchopulmonary displasia (BPD)

  Postnatal age of 28 days or till discharge

• Mortality

  Up to postmenstrual 52 weeks or till discharge

Study Arms (2)

Weight+6

ACTIVE COMPARATOR

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.

Other: Weight+6

NTL+1

ACTIVE COMPARATOR

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.

Other: NTL+1

Interventions

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.

Weight+6

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.

NTL+1

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (5)

Zekai Tahir Burak Maternity Teaching Hospital

Ankara, 06320, Turkey (Türkiye)

Location

Diyarbakır Gazi Yaşargil Training and Research Hospital

Diyarbakır, Turkey (Türkiye)

Location

Ege University

Izmir, Turkey (Türkiye)

Location

Izmir Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Şanlıurfa Training and Research Hospital

Sanliurfa, Turkey (Türkiye)

Location

Study Officials

• Mehmet Yekta Oncel, M.D.

  Zekai Tahir Burak Women's Health Research and Education Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The radiologist who will determine endotracheal tube placement in the X-ray
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor, M.D.

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 19, 2018
• Study Start: January 15, 2018
• Primary Completion: July 15, 2018
• Study Completion: September 1, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

TU (5)