Endotracheal Tube Placement in Neonatal Intubation

Neonatal Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591835
• Other study ID #: TEP2018133
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: December 2018
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 1, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Respiratory Failure
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Maternity Teaching Hospital	Ankara
Turkey	Diyarbakir Gazi Yasargil Training and Research Hospital	Diyarbakir
Turkey	Ege University	Izmir
Turkey	Izmir Tepecik Training and Research Hospital	Izmir
Turkey	Sanliurfa Training and Research Hospital	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

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