Back to resultsEndotracheal Tube Placement in Neonatal Intubation
Primary Purpose
Neonatal Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Weight+6
NTL+1
Sponsored by
About this trial
This is an interventional supportive care trial for Neonatal Respiratory Failure focused on measuring Nasal septum-tragus length; newborn
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
Sites / Locations
- Zekai Tahir Burak Maternity Teaching Hospital
- Diyarbakır Gazi Yaşargil Training and Research Hospital
- Ege University
- Izmir Tepecik Training and Research Hospital
- Şanlıurfa Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Weight+6
NTL+1
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Pneumothorax
Pneumothorax by transillumination confirmed by chest x-ray.
Bronchopulmonary displasia (BPD)
BPD will be defined according to National Institutes of Health criteria.
Mortality
We will record who died until discharge
Full Information
NCT ID
NCT03591835
First Posted
June 22, 2018
Last Updated
December 10, 2018
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03591835
Brief Title
Endotracheal Tube Placement in Neonatal Intubation
Official Title
Is Nasal Septum-tragus Length Safe in Neonatal Endotracheal Intubation?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Failure
Keywords
Nasal septum-tragus length; newborn
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The radiologist who will determine endotracheal tube placement in the X-ray
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weight+6
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NTL+1
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Weight+6
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
NTL+1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correct placement of the ETT
Description
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).
Time Frame
Up to 1 hour
Secondary Outcome Measure Information:
Title
Pneumothorax
Description
Pneumothorax by transillumination confirmed by chest x-ray.
Time Frame
Up to postmenstrual 52 weeks or till discharge
Title
Bronchopulmonary displasia (BPD)
Description
BPD will be defined according to National Institutes of Health criteria.
Time Frame
Postnatal age of 28 days or till discharge
Title
Mortality
Description
We will record who died until discharge
Time Frame
Up to postmenstrual 52 weeks or till discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Yekta Oncel, M.D.
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital
City
Ankara
ZIP/Postal Code
06320
Country
Turkey
Facility Name
Diyarbakır Gazi Yaşargil Training and Research Hospital
City
Diyarbakır
Country
Turkey
Facility Name
Ege University
City
İzmir
Country
Turkey
Facility Name
Izmir Tepecik Training and Research Hospital
City
Izmir
Country
Turkey
Facility Name
Şanlıurfa Training and Research Hospital
City
Şanlıurfa
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Endotracheal Tube Placement in Neonatal Intubation
We'll reach out to this number within 24 hrs