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CompletedNCT02181894Updated Jul 26, 2018

Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes (ETT).

An observational study in Infant Showing No Response to Resuscitation, Ventilator Adverse Event and Apparent Life Threatening Event in Newborn and Infant, sponsored by University of Colorado, Denver. Completed at 5 sites in 2 countries. Open to participants aged 1 Minute to 72 Hours. Per ClinicalTrials.gov, last updated 2018-07-26.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8
Ages
1 Minute to 72 Hours
Sex
All
01

Study summary

Placing artificial airways in infants is often performed under emergent life-saving conditions, which necessitates a procedure that is both accurate and efficient. Intubations of the newborn are often necessary before an accurate weight can be reported and estimations are often inaccurate. The current national standard uses body weight to predict the appropriate tube depth yet this approach tends to place the tube too deep for the smallest and most vulnerable neonate; and placement accuracy of any size infant is only 50-70%. The consequence of malpositioned ETTs resulting from poor oxygenation, lung hyperinflation, pneumothoraces and death has been suggested to cost $20 to $54 million annually.

The morbidity and the financial impact suggest an optimal and accurate approach to place ETT in neonates has not been identified. Other methods to estimate the proper depth of the orotracheal tube have shown promise yet no comparison studies have been performed. Identifying the most accurate method to safely place neonatal orotracheal tubes will improve placement precision and reduce adverse events and their associated costs.

Hypothesis

Compared to weight, sternal to xyphoid length and shoulder to elbow length, the nasal to tragus length will become the most accurate method for predicting the safe depth of orally placed neonatal endotracheal tubes.

02

Conditions studied

  • Infant Showing No Response to Resuscitation
  • Ventilator Adverse Event
  • Apparent Life Threatening Event in Newborn and Infant

Keywords

  • Infant
  • Newborn
  • Neonate
  • Intubation
  • Neonatal resuscitation
03

Who can participate

Ages eligible
1 Minute to 72 Hours
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Infants \<72 hours of age and orally intubated

Inclusion criteria

  • Infants orally intubated and admitted into the Neonatal Intensive Care Unit.

Exclusion criteria

Exclusion Criteria:

  • Previous intubation
  • Hydrops fetalis
  • Thoracic congenital anomalies
  • Facial abnormalities
  • Naso-tracheal intubation
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8 participants (actual)
Patient registry
No

Groups and cohorts

  • Orally intubated infants

    Subjects will be \<72 hours of age and orally intubated. Following consent, four measures will be reported (i.e. body weight, nasal to tragus length, suprasternal notch to xyphoid process and shoulder to elbow length). Measures will be compared against a chest x-ray and placement of ETT at the subjects lip to identify the most accurate method to place endotracheal tubes in the newborn.

05

What researchers measure

Primary outcomes

  1. The differences between 4 measurement methods in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.

    Time frame: Up to 3 years

Secondary outcomes

  1. The differences in head position in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.

    Time frame: Up to 3 years

06

Study locations

5 sites
  • Kaiser Permanente, Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • The Rotunda Hospital
    Dublin 1, Ireland
  • The Coombe Women & Infants University Hospital
    Dublin 8, Ireland
07

Registry details

Key details

Study ID
NCT02181894
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Jul 4, 2014
Start date
Nov 2014
Primary completion
Jul 1, 2016
Completion
Jul 1, 2016
Last update
Jul 26, 2018

Study contacts

Susan L Moran, DNP APRN NNP-BC FFNMRCSI
principal investigator · Children's Hospital Colorado

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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