Endotracheal Tube Placement in Neonatal Intubation

Not Applicable

Completed

• Conditions: Neonatal Respiratory Failure

• Registration Number: NCT03591835
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

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).

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-06-22
• Primary Completion: 2018-07-15
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-19
• Study Completion: 2018-09-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Correct placement of the ETT	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 Outcome Measures

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

Trial Locations

Locations (5)

Zekai Tahir Burak Maternity Teaching Hospital; 🇹🇷 Ankara, Turkey

Diyarbakır Gazi Yaşargil Training and Research Hospital; 🇹🇷 Diyarbakır, Turkey

Ege University; 🇹🇷 İzmir, Turkey

Izmir Tepecik Training and Research Hospital; 🇹🇷 Izmir, Turkey

Şanlıurfa Training and Research Hospital; 🇹🇷 Şanlıurfa, Turkey