Clinical trial NCT02181894: Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes (ETT).
Official title: Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Showing No Response to Resuscitation
Ventilator Adverse Event
Apparent Life Threatening Event in Newborn and Infant
Keywords: Infant
Newborn
Neonate
Intubation
Neonatal resuscitation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-07-04
Enrollment: 8
Sex: ALL
Minimum age (years): 1
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants \<72 hours of age and orally intubated

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: Up to 3 years
Secondary outcomes:
measure: The differences in head position in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente, Los Angeles Medical Center
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Dublin 1
country: Ireland
facility: The Rotunda Hospital
city: Dublin 8
country: Ireland
facility: The Coombe Women & Infants University Hospital
Study officials:
affiliation: Children's Hospital Colorado
name: Susan L Moran, DNP APRN NNP-BC FFNMRCSI
role: PRINCIPAL_INVESTIGATOR
References: