Endotracheal Tube Placement in Neonatal Intubation

Is Nasal Septum-tragus Length Safe in Neonatal Endotracheal 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.

Study Overview

• Status: Completed
• Conditions: Neonatal Respiratory Failure
• Intervention / Treatment: Other: Weight+6; Other: NTL+1

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).

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06320
    • Zekai Tahir Burak Maternity Teaching Hospital
  • Diyarbakır, Turkey
    • Diyarbakır Gazi Yaşargil Training and Research Hospital
  • Izmir, Turkey
    • Izmir Tepecik Training and Research Hospital
  • İzmir, Turkey
    • Ege University
  • Şanlıurfa, Turkey
    • Sanlıurfa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Weight+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.	Other: Weight+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.
ACTIVE_COMPARATOR: NTL+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.	Other: NTL+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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumothorax	Pneumothorax by transillumination confirmed by chest x-ray.	Up to postmenstrual 52 weeks or till discharge
Bronchopulmonary displasia (BPD)	BPD will be defined according to National Institutes of Health criteria.	Postnatal age of 28 days or till discharge
Mortality	We will record who died until discharge	Up to postmenstrual 52 weeks or till discharge

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
• Investigators: Study Director: Mehmet Yekta Oncel, M.D., Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2018
• Primary Completion (ACTUAL): July 15, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (ACTUAL): July 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Nasal septum-tragus length; newborn
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: TEP2018133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No