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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02181894
Enrollment
8
Registered
2014-07-04
Start date
2014-11-30
Completion date
2016-07-01
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Infant, Newborn, Neonate, Intubation, Neonatal resuscitation

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.

Interventions

None listed

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 72 Hours
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.Up to 3 years

Secondary

MeasureTime frame
The differences in head position in placing a neonatal ETT between the lower border of T1 and upper margin of T3 on chest radiograph.Up to 3 years

Countries

Ireland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026