Clinical trial NCT03591835: Endotracheal Tube Placement in Neonatal Intubation
Official title: Is Nasal Septum-tragus Length Safe in Neonatal Endotracheal Intubation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Respiratory Failure
Keywords: Nasal septum-tragus length; newborn
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Correct placement of the ETT
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Pneumothorax
timeFrame: Up to postmenstrual 52 weeks or till discharge
measure: Bronchopulmonary displasia (BPD)
timeFrame: Postnatal age of 28 days or till discharge
measure: Mortality
timeFrame: Up to postmenstrual 52 weeks or till discharge
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
city: Diyarbakır
country: Turkey
facility: Diyarbakır Gazi Yaşargil Training and Research Hospital
city: İzmir
country: Turkey
facility: Ege University
city: Izmir
country: Turkey
facility: Izmir Tepecik Training and Research Hospital
city: Şanlıurfa
country: Turkey
facility: Şanlıurfa Training and Research Hospital
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Mehmet Yekta Oncel, M.D.
role: STUDY_DIRECTOR
References: